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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, Natural
510(k) Number K896554
Device Name GUT SUTURES
Applicant
Look, Inc.
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Applicant Contact JOHN M PACKMAN
Correspondent
Look, Inc.
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Correspondent Contact JOHN M PACKMAN
Regulation Number878.4830
Classification Product Code
GAL  
Date Received11/17/1989
Decision Date 05/31/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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