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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K971337
Device Name EPITECH ISLAND DRESSINGS
Applicant
RYNEL LTD, INC.
ROUTE 27
BOOTHBAY,  ME  04537
Applicant Contact TIM THOMSON
Correspondent
RYNEL LTD, INC.
ROUTE 27
BOOTHBAY,  ME  04537
Correspondent Contact TIM THOMSON
Regulation Number880.5090
Classification Product Code
KMF  
Date Received04/10/1997
Decision Date 07/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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