FDA 510(k) Application Details - K123035

Device Classification Name Clamp, Vascular

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510(K) Number K123035
Device Name Clamp, Vascular
Applicant Perouse Medical
135, ROUTE NEUVE
IRIGNY 69 540 FR
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Contact CAROLINE DAURELLE
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 09/28/2012
Decision Date 11/28/2012
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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