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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K961067
Device Name BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET
Applicant
Medtrak Intl., Inc.
9841 Broken Land Pkwy., #107
Columbia,  MD  21046
Applicant Contact CAROLYN DERRER
Correspondent
Medtrak Intl., Inc.
9841 Broken Land Pkwy., #107
Columbia,  MD  21046
Correspondent Contact CAROLYN DERRER
Classification Product Code
MGQ  
Date Received03/18/1996
Decision Date 05/16/1996
Decision Substantially Equivalent (SESE)
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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