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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 K994001
Device Name POLYGLYCOLIC ACID
Applicant
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
157 WINDDANCE DR.
CHICAGO,  IL  60046
Applicant Contact MAIN M GHAZAL
Correspondent
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
157 WINDDANCE DR.
CHICAGO,  IL  60046
Correspondent Contact MAIN M GHAZAL
Regulation Number878.4493
Classification Product Code
GAM  
Date Received11/24/1999
Decision Date 02/09/2000
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
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