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FDA 510(k) Application Details - K955554
Device Classification Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K955554
Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant
NORTH AMERICAN INSTRUMENT CORP.
PRUYNS ISLAND RD.
GLENS FALLS, NY 12801 US
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Contact
MARY M RUBIN
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Regulation Number
870.4290
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Classification Product Code
DTL
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More FDA Info for this Product Code
Date Received
12/05/1995
Decision Date
03/04/1996
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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