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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, silk
510(k) Number K993999
Device Name SILK
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 Number878.5030
Classification Product Code
GAP  
Date Received11/24/1999
Decision Date 02/04/2000
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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