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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sheet, Burn
510(k) Number K760210
Device Name BLANKET, WATER-JEL FIRE
Applicant
American Safety
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Safety
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5180
Classification Product Code
FPY  
Date Received07/12/1976
Decision Date 08/11/1976
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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