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FDA 510(k) Application Details - K062569
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
DXC
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More FDA Info for this Product Code
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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