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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 K063536
Device Name POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
Applicant
Tyco Healthcare Group
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact ROBERT ZOTT
Correspondent
Tyco Healthcare Group
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact ROBERT ZOTT
Regulation Number878.4493
Classification Product Code
GAM  
Date Received11/22/2006
Decision Date 01/29/2007
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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