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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 K062366
Device Name OPTIME, SINUSORB PGA
Applicant
PETERS SURGICAL
42 RUE BENOIT FRACHON
BOBIGNY,  FR 93013
Applicant Contact ANNIE LASSERRE
Correspondent
PETERS SURGICAL
42 RUE BENOIT FRACHON
BOBIGNY,  FR 93013
Correspondent Contact ANNIE LASSERRE
Regulation Number878.4493
Classification Product Code
GAM  
Date Received08/14/2006
Decision Date 10/02/2006
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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