EPITECH ISLAND DRESSINGS

Bandage, Liquid

RYNEL LTD, INC.

The following data is part of a premarket notification filed by Rynel Ltd, Inc. with the FDA for Epitech Island Dressings.

Pre-market Notification Details

Device IDK971337
510k NumberK971337
Device Name:EPITECH ISLAND DRESSINGS
ClassificationBandage, Liquid
Applicant RYNEL LTD, INC. ROUTE 27 Boothbay,  ME  04537
ContactTim Thomson
CorrespondentTim Thomson
RYNEL LTD, INC. ROUTE 27 Boothbay,  ME  04537
Product CodeKMF  
CFR Regulation Number880.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-10
Decision Date1997-07-09
Summary:summary

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