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FDA 510(k) Application Details - K963749
Device Classification Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K963749
Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant
MAXXIM MEDICAL
100 EAST 15TH ST.
SUITE 320
FORT WORTH, TX 76102 US
Other 510(k) Applications for this Company
Contact
RICHARD A HAMER
Other 510(k) Applications for this Contact
Regulation Number
870.4290
More FDA Info for this Regulation Number
Classification Product Code
DTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/18/1996
Decision Date
12/17/1996
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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