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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, Polyethylene
510(k) Number K931916
Device Name SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER
Applicant
Surgimetrics International, Ltd.
4233 Thamesgate Close
Norcross,  GA  30092
Applicant Contact RON LAPORTE
Correspondent
Surgimetrics International, Ltd.
4233 Thamesgate Close
Norcross,  GA  30092
Correspondent Contact RON LAPORTE
Regulation Number878.5000
Classification Product Code
GAT  
Date Received04/16/1993
Decision Date 03/03/1994
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
Predetermined Change
Control Plan Authorized		 No
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