ADHEROL SEPP APPLICATOR

Dressing, Wound, Drug

MEDI-FLEX HOSPITAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Medi-flex Hospital Products, Inc. with the FDA for Adherol Sepp Applicator.

Pre-market Notification Details

Device IDK952007
510k NumberK952007
Device Name:ADHEROL SEPP APPLICATOR
ClassificationDressing, Wound, Drug
Applicant MEDI-FLEX HOSPITAL PRODUCTS, INC. 8717 W. 110TH ST., SUITE 750 Overland Park,  KS  66210 -2103
ContactOrlando Cordova
CorrespondentOrlando Cordova
MEDI-FLEX HOSPITAL PRODUCTS, INC. 8717 W. 110TH ST., SUITE 750 Overland Park,  KS  66210 -2103
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-28
Decision Date1995-06-08

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