MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER

Reservoir, Blood, Cardiopulmonary Bypass

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Maxima* Collapsible Venous Reservoir Bag & Holder.

Pre-market Notification Details

Device IDK873423
510k NumberK873423
Device Name:MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia,  PA  19406
ContactDenise A Carpenter
CorrespondentDenise A Carpenter
JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia,  PA  19406
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-25
Decision Date1987-11-06

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