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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K040282
Device Name ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
Applicant
Internacional Farmaceutica, S.A. DE C.V.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
Internacional Farmaceutica, S.A. DE C.V.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number878.4493
Classification Product Code
GAM  
Date Received02/06/2004
Decision Date 04/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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