SUR-FIT NIGHT DRAINAGE CONTAINER SET

Collector, Urine, (and Accessories) For Indwelling Catheter

CONVATEC, A DIVISION OF E.R. SQUIBB & SONS

The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Sur-fit Night Drainage Container Set.

Pre-market Notification Details

Device IDK842395
510k NumberK842395
Device Name:SUR-FIT NIGHT DRAINAGE CONTAINER SET
ClassificationCollector, Urine, (and Accessories) For Indwelling Catheter
Applicant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKNX  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-19
Decision Date1984-08-08

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