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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
510(k) Number K060465
Device Name PREMIO
Applicant
Peters Surgical
42 Rue Benoit Frachon
Z.I. Les Vignes
Bobigny,  FR 93013
Applicant Contact ANNIE LASSERRE
Correspondent
Peters Surgical
42 Rue Benoit Frachon
Z.I. Les Vignes
Bobigny,  FR 93013
Correspondent Contact ANNIE LASSERRE
Regulation Number878.5010
Classification Product Code
MXW  
Date Received02/22/2006
Decision Date 01/17/2007
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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