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FDA 510(k) Application Details - K020257
Device Classification Name
System, Balloon, Intra-Aortic And Control
More FDA Info for this Device
510(K) Number
K020257
Device Name
System, Balloon, Intra-Aortic And Control
Applicant
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD, NJ 07004-3206 US
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Contact
JOANN WOLF
Other 510(k) Applications for this Contact
Regulation Number
870.3535
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Classification Product Code
DSP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/24/2002
Decision Date
04/24/2002
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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