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HQ 559388

February 13, 1996

MAR-2-05 RR:TC:SM 559388 KR


Robert L. Follick
Follick & Bessich, P.C.
225 Broadway, Suite 500
New York, NY 10007

RE: Country of origin marking on containers for surgical instruments; 19 CFR §134.46; 19 CFR §134.43(a).

Dear Mr. Follick:

This is in reply to your letter on behalf of United States Surgical Corporation to our New York office, dated July 5, 1995, and subsequently forwarded to this office, requesting a ruling concerning the country of origin marking requirements applicable to imported surgical equipment. We received additional correspondence from you dated August 17, 1995, and November 27, 1995, and a meeting was held with you on November 13, 1995. You submitted many samples of adhesive labels you wish to place on the surgical instrument containers, photocopies of two boxes in which the back support waistbands are imported, and an actual box for our review.


United States Surgical Corporation ("USSC") imports various surgical equipment into the U.S. USSC does not want to have the surgical equipment itself marked with the country of origin. Instead, USSC requests to be allowed to place adhesive labels on the containers of the surgical instruments which will give product name and information, including the country of origin.

The adhesive labels accompanying the original submission varied. All the adhesive labels contained the US address of USSC, "Norwalk, Connecticut". Some of the labels stated at the bottom "Made in South Korea". Some of the labels had the statement "Made in South Korea" in the middle of other product copyright and trademark information. As an example, one of the products which use these latter labels reads:

Auto Suture*
Blunt tip instrument

Contents: One (1) SPINAL ELEVATOR-Blunt Tip 10mm/10mm Instrument

Contents are provided NONSTERILE


CAUTION: Federal (USA) law restricts this device to sale, distribution, and use by, or on the order of, a physician.

Copyright © 1994,
United States Surgical Corporation.
All rights Reserved. Made in South Korea. *Trademark of United States Surgical Corporation Manufactured for:
United States Surgical Corporation
Norwalk, Connecticut 06856.

At the end of the November 13, 1995, meeting, you agreed to place the country of origin "Made In South Korea", at the bottom of the adhesive label. The facsimile dated November 27, 1995, contained a copy of a the label you intend to use, which was the same as the label described above, but which stated at the bottom of the label "Made In South Korea".


1) May the surgical instruments be marked with their country of origin using an adhesive label on their container rather than pursuant to the special marking requirements of 19 CFR §134.43(a)?

2) Whether the country of origin marking appearing on the adhesive labels satisfies the country of origin marking statute and regulations.


Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every article of foreign origin imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. 1304 was "that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will." United States v. Friedlander & Co., 27 C.C.P.A. 297 at 302; C.A.D. 104 (1940).

Part 134, Customs Regulations (19 CFR Part 134), implements the country of origin marking requirements and exceptions of 19 U.S.C. §1304. Section 134.41(b), Customs Regulations (19 CFR §134.41(b), mandates that the ultimate purchaser in the U.S. must be able to find the marking easily and read it without strain.

In addition, §134.43(a), Customs Regulations (19 CFR §134.43(a)), places special marking requirements on certain products, including surgical instruments. 19 CFR §134.43(a), in pertinent part, reads:
articles of a class or kind listed below shall be marked legibly and conspicuously by die stamping, cast-in-the-mold lettering, etching (acid or electrolytic), engraving, or by means of metal plates which bear the prescribed marking and which are securely attached to the article in a conspicuous place by welding, screws, or rivets: knives, forks, steels, cleavers, clippers, shears, scissors, safety razors, blades for safety razors, surgical instruments, dental instruments, scientific and laboratory instruments, pliers, pincers, nippers and hinged hand tools for holding and splicing wire, vacuum containers, and parts of the above articles. (emphasis added)

However, Customs has determined that articles such as surgical instruments which are subject to the special marking requirements of 19 CFR §134.43(a), may be excepted from the special individual marking requirements if the marking of their containers will satisfy the requirements of 19 CFR §134.32(d). See HQ 735378 (February 10, 1995); HQ 734703 (December 2, 1992); HQ 733301 (August 8, 1990). Therefore, in the instant case, if the articles will be packaged in a properly marked container which will reach the ultimate purchaser unopened, the surgical instruments may be excepted from the special marking requirements of 19 CFR §134.43(a).

Section 134.41(b), Customs Regulations (19 CFR §134.41(b), mandates that the ultimate purchaser in the U.S. must be able to find the marking easily and read it without strain. The requirement is that the location must be "conspicuous". See 19 CFR §134.11. Further, Section 134.46, Customs Regulations (19 CFR §134.46), requires that when the name of any city or locality in the U.S., or the name of any foreign country or locality other than the name of the country or locality in which the article was manufactured or produced, appears on an imported article or its container, there shall appear, legibly and permanently, in close proximity to such words, letters or name, and in at least a comparable size, the name of the country of origin preceded by "Made in," "Product of," or other words of similar meaning. Customs has ruled that in order to satisfy the close proximity requirement, the country of origin marking must appear on the same side(s) or surface(s) in which the name of the locality other than the country of origin appears. HQ 708994 (April 24, 1978). The purpose of 19 CFR §134.46 is to prevent the possibility of misleading or deceiving the ultimate purchaser as to the origin of the imported article.

In this situation, the country of origin marking appearing on the originally submitted labels, as described in detail above, was difficult to locate among the other printing on the labels and, therefore, was not conspicuous. However, you have agreed to place the country of origin at the bottom of the adhesive label. We find that location to be conspicuous. Further, since the country of origin on the new labels appears on the same label as the U.S. address, is in equal size print to the U.S. address and is preceded by the words "Made In", we find that the label satisfies the requirements of 19 CFR §134.46.


Based on the information provided, the country of origin marking appearing on adhesive label as appearing on the November 27, 1995, facsimile satisfies Customs statutory and regulatory requirements.

A copy of this ruling letter should be attached to the entry documents filed at the time this merchandise is entered. If the documents have been filed without a copy, this ruling should be brought to the attention of the Customs officer handling the transaction.


John Durant, Director
Tariff Classification Appeals Division

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