WOUND MANAGER(TM) - STERILE

Dressing, Wound, Drug

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 Wound Manager(tm) - Sterile.

Pre-market Notification Details

Device IDK862935
510k NumberK862935
Device Name:WOUND MANAGER(TM) - STERILE
ClassificationDressing, Wound, Drug
Applicant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton,  NJ  08540
ContactPeter C Kallos
CorrespondentPeter C Kallos
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton,  NJ  08540
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-04
Decision Date1986-08-20

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