BAG, URINE

Collector, Urine, (and Accessories) For Indwelling Catheter

GAINOR MEDICAL EUROPE, LTD.

The following data is part of a premarket notification filed by Gainor Medical Europe, Ltd. with the FDA for Bag, Urine.

Pre-market Notification Details

Device IDK902417
510k NumberK902417
Device Name:BAG, URINE
ClassificationCollector, Urine, (and Accessories) For Indwelling Catheter
Applicant GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough,  GA  30253 -0353
ContactMark Gainor
CorrespondentMark Gainor
GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough,  GA  30253 -0353
Product CodeKNX  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-31
Decision Date1990-07-16

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