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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 K921470
Device Name BURNSHIELD FIRE BLANKET
Applicant
Levtrade Intl. (Pty) , Ltd.
Perseus Park, Priory Rd.,
Lynnwood Ridge
Petoria, South Africa,  ZA
Applicant Contact VIENINGS
Correspondent
Levtrade Intl. (Pty) , Ltd.
Perseus Park, Priory Rd.,
Lynnwood Ridge
Petoria, South Africa,  ZA
Correspondent Contact VIENINGS
Regulation Number880.5180
Classification Product Code
FPY  
Date Received03/27/1992
Decision Date 04/20/1993
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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