CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)

Collector, Urine, (and Accessories) For Indwelling Catheter

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Conveen(r) Night Drainage Bag (2000 Ml).

Pre-market Notification Details

Device IDK871610
510k NumberK871610
Device Name:CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
ClassificationCollector, Urine, (and Accessories) For Indwelling Catheter
Applicant COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth,  TX  76162
ContactRichard A Hamer
CorrespondentRichard A Hamer
COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth,  TX  76162
Product CodeKNX  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-24
Decision Date1987-06-10

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