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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K071281
Device Name UNIRING - ANNULOPLASTY RING WITH SIZERS
Applicant
Peters Surgical
Z.I. Les Vignes
42 Rue Benoit Frachon
Bobigny,  FR 93013
Applicant Contact ROBERT RENAULT
Correspondent
Peters Surgical
Z.I. Les Vignes
42 Rue Benoit Frachon
Bobigny,  FR 93013
Correspondent Contact ROBERT RENAULT
Regulation Number870.3800
Classification Product Code
KRH  
Date Received05/07/2007
Decision Date 08/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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