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FDA 510(k) Application Details - K963920
Device Classification Name
System, Balloon, Intra-Aortic And Control
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510(K) Number
K963920
Device Name
System, Balloon, Intra-Aortic And Control
Applicant
ARROW INTL., INC.
3000 BERNVILLE RD.
READING, PA 19605 US
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Contact
THOMAS D NICKEL
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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
09/30/1996
Decision Date
06/17/1997
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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