FDA 510(k) Application Details - K071281

Device Classification Name Ring, Annuloplasty

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510(K) Number K071281
Device Name Ring, Annuloplasty
Applicant PETERS SURGICAL
Z.I. LES VIGNES
42 RUE BENOIT FRACHON
BOBIGNY 93013 FR
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Contact ROBERT RENAULT
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Regulation Number 870.3800

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Classification Product Code KRH
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Date Received 05/07/2007
Decision Date 08/03/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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