ACTIDERM*-OPAQUE

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 Actiderm*-opaque.

Pre-market Notification Details

Device IDK892232
510k NumberK892232
Device Name:ACTIDERM*-OPAQUE
ClassificationDressing, Wound, Drug
Applicant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton,  NJ  08540
ContactMark Citron
CorrespondentMark Citron
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 (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-04
Decision Date1989-05-05

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