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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, polypropylene
510(k) Number K052701
Device Name COROLENE
Applicant
PETERS SURGICAL
42 RUE BENOIT FRANCHON
BOBIGNY,  FR 93013
Applicant Contact ANNIE LASSERRE
Correspondent
PETERS SURGICAL
42 RUE BENOIT FRANCHON
BOBIGNY,  FR 93013
Correspondent Contact ANNIE LASSERRE
Regulation Number878.5010
Classification Product Code
GAW  
Date Received09/28/2005
Decision Date 12/13/2005
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
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