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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, Synthetic, Polyamide
510(k) Number K903029
Device Name STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE
Applicant
LOOK, INC.
WASHINGTON SQUARE
1050 CONNECTICUT AVENUE N.W.
WASHINGTON,  DC  20036
Applicant Contact JOHN M PACKMAN
Correspondent
LOOK, INC.
WASHINGTON SQUARE
1050 CONNECTICUT AVENUE N.W.
WASHINGTON,  DC  20036
Correspondent Contact JOHN M PACKMAN
Regulation Number878.5020
Classification Product Code
GAR  
Date Received07/10/1990
Decision Date 10/25/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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