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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 K951909
Device Name RYNEL MEDICAL FOAM
Applicant
Rynel, Ltd. Inc.
Rte. 27
Boothbay,  ME  04537
Applicant Contact TIM THOMSON
Correspondent
Rynel, Ltd. Inc.
Rte. 27
Boothbay,  ME  04537
Correspondent Contact TIM THOMSON
Regulation Number880.5090
Classification Product Code
KMF  
Date Received04/24/1995
Decision Date 06/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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