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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name First Aid Kit With Drug
510(k) Number K952561
Device Name WATER JEL BURN KIT
Applicant
Water-Jel Technologies, Inc.
243 Veterans Blvd.
Carlstadt,  NJ  07072
Applicant Contact CORNELIA DAMSKY
Correspondent
Water-Jel Technologies, Inc.
243 Veterans Blvd.
Carlstadt,  NJ  07072
Correspondent Contact CORNELIA DAMSKY
Classification Product Code
LRR  
Date Received06/02/1995
Decision Date 07/14/1995
Decision Substantially Equivalent (SESE)
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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