DRAIN/PRIMING/RECIRCULATION BAG

Accessories, Blood Circuit, Hemodialysis

HAEMOTRONIC, INC.

The following data is part of a premarket notification filed by Haemotronic, Inc. with the FDA for Drain/priming/recirculation Bag.

Pre-market Notification Details

Device IDK913361
510k NumberK913361
Device Name:DRAIN/PRIMING/RECIRCULATION BAG
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant HAEMOTRONIC, INC. 45 KULICK RD. Fairfield,  NJ  07004
ContactWiller Ghelfi
CorrespondentWiller Ghelfi
HAEMOTRONIC, INC. 45 KULICK RD. Fairfield,  NJ  07004
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-29
Decision Date1992-03-30

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