FDA 510(k) Application Details - K062569

Device Classification Name Clamp, Vascular

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510(K) Number K062569
Device Name Clamp, Vascular
Applicant DATASCOPE CORP.
1300 MACARTHUR BLVD
MAHWAH, NJ 07430 US
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Contact SUSAN MANDY
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 08/31/2006
Decision Date 02/14/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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