ELAN-E DISPOSALBE DRAPE

Drape, Surgical

DERMACARE PRODUCTS, INC.

The following data is part of a premarket notification filed by Dermacare Products, Inc. with the FDA for Elan-e Disposalbe Drape.

Pre-market Notification Details

Device IDK882494
510k NumberK882494
Device Name:ELAN-E DISPOSALBE DRAPE
ClassificationDrape, Surgical
Applicant DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville,  KT  40214
ContactKen J Potts
CorrespondentKen J Potts
DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville,  KT  40214
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-16
Decision Date1988-07-08

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