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NY H86513




December 19, 2001

CLA-2-30:RR:NC:2:238 H86513

CATEGORY: CLASSIFICATION

TARIFF NO.: 3001.90.0000

Mr. Richard Ingrao
Expeditors Tradewin, LLC
11101 Metro Airport Center Drive
Suite 110
Romulus, MI 48174

RE: The tariff classification of the CorRestore Patch from Canada

Dear Mr. Ingrao:

In your letter dated December 3, 2001, on behalf of your client, Somanetics Corporation, you requested a tariff classification ruling.

The subject product, CorRestore Patch, consists of a sterile, oval-shaped patch made from an animal substance. It is intended for use in humans as an intracardiac graft for cardiac reconstruction and repair. The patch may be sold alone or as part of a kit. When sold as part of a kit, the kit will also include a suture strip made from an animal substance and/or 20 pledgets made from an animal substance and/or various sterile sutures. The pledgets and suture strip will be processed, sterilized and packaged in the same manner as the patch. The patch, suture strip (when included) and pledgets (when included) will be put up packaged in shrink-wrapped plastic jars. Instructions and a monitor indicating exposure to freezing temperatures will be included in each kit. The sutures, when ordered as an option, will remain in their original, sterile packaging and placed in a separate portion of the kit. In our opinion, pursuant to Rule 3(b) of the General Rules of Interpretation, HTS, when the CorRestore Patch is imported put up as part of one or more of the kits described above, the essential character will be imparted by the patch.

The applicable subheading for the CorRestore Patch, imported alone or put up as part of one or more of the above-described kits, will be 3001.90.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for “[o]ther human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included: Other. The general rate of duty will be free. The general rate of duty will remain unchanged in 2002.

This merchandise may be subject to the regulations of the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, Office of Health and Safety, Biosafety Branch. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number 404-633-5313.

This merchandise may also be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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