QUEST VEIN GRAFT PERFUSION SET

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

QUEST MEDICAL, INC.

The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Quest Vein Graft Perfusion Set.

Pre-market Notification Details

Device IDK952531
510k NumberK952531
Device Name:QUEST VEIN GRAFT PERFUSION SET
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen,  TX  75002
ContactDrew Johnson
CorrespondentDrew Johnson
QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen,  TX  75002
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-01
Decision Date1995-08-24

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