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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 K900443
Device Name BURNS CASUALTY SHEET LIMB WRAP
Applicant
Pilgrim Medical Services
The Old Coach House
Chapel Rd., Rotherwas, Hereford
England Hr2 6sx,  GB
Applicant Contact BROWN
Correspondent
Pilgrim Medical Services
The Old Coach House
Chapel Rd., Rotherwas, Hereford
England Hr2 6sx,  GB
Correspondent Contact BROWN
Regulation Number880.5180
Classification Product Code
FPY  
Date Received01/30/1990
Decision Date 07/03/1990
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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