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FDA 510(k) Application Details - K965236
Device Classification Name
System, Balloon, Intra-Aortic And Control
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510(K) Number
K965236
Device Name
System, Balloon, Intra-Aortic And Control
Applicant
DATASCOPE CORP.
580 WINTERS AVE.
PARAMUS, NJ 07652 US
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Contact
WILLIAM GOELLER
Other 510(k) Applications for this Contact
Regulation Number
870.3535
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Classification Product Code
DSP
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More FDA Info for this Product Code
Date Received
12/31/1996
Decision Date
07/01/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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