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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 K060163
Device Name CARDIOFLON, CARDIOXYL
Applicant
Peters Surgical
Z.I. Les Vignes
42 Rue Benoit Frachon
Bobigny,  FR 93013
Applicant Contact ANNIE LASSERRE
Correspondent
Peters Surgical
Z.I. Les Vignes
42 Rue Benoit Frachon
Bobigny,  FR 93013
Correspondent Contact ANNIE LASSERRE
Regulation Number878.5000
Classification Product Code
GAT  
Date Received01/23/2006
Decision Date 10/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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