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FDA 510(k) Application Details - K071281
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
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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More FDA Info for this Product Code
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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