CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION

Device, Paste-on For Incontinence, Sterile

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 Convatec Little Ones Pediatric Urine Collection.

Pre-market Notification Details

Device IDK924755
510k NumberK924755
Device Name:CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION
ClassificationDevice, Paste-on For Incontinence, Sterile
Applicant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton,  NJ  08540
ContactMarilyn Dreyling
CorrespondentMarilyn Dreyling
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton,  NJ  08540
Product CodeEXI  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-23
Decision Date1993-06-22

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