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FPY — Sheet, Burn Class I

FDA Device Classification

Classification Details

Product Code
FPY
Device Class
Class I
Regulation Number
880.5180
Submission Type
Review Panel
SU
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K930759consolidated products and servicesCP & S STERILE BURN SHEETJanuary 21, 1994
K921471levtrade intl. (pty)BURNSHIELD TRAUMA DRESSINGApril 20, 1993
K921470levtrade intl. (pty)BURNSHIELD FIRE BLANKETApril 20, 1993
K926290gam industriesBURN SHEETApril 20, 1993
K900443pilgrim medical servicesBURNS CASUALTY SHEET LIMB WRAPJuly 3, 1990
K900441pilgrim medical servicesBURNS CASUALTY SHEETJuly 3, 1990
K900442pilgrim medical servicesBURNS CASUALTY SHEET BURN ROLLJuly 3, 1990
K871740acme unitedLYOSHEET SURGICAL SHEET FOR BURNSJune 9, 1987
K853145kendalKENDALL CURITY BURN PADAugust 30, 1985
K841898reed productsFIRST RESPONSE EMERG. MEDICSL - BURNSAugust 14, 1984
K820994american convertors div., american pharmasealABSORB FURN SHEETMay 13, 1982
K800064trilling resourcesWATER JEL FIRE BLANKETMarch 25, 1980
K792432american medical disposableTEMPORARY BURN SHEET WITH PERFORATEDDecember 20, 1979
K792433american medical disposableTEMPORARY BURN SHEET WITH PERFORATEDDecember 20, 1979
K780418owenbyBURN DRESSING PADApril 10, 1978
K760210american safetyBLANKET, WATER-JEL FIREAugust 11, 1976
K760365winn hirsch and assocBLANKET, BURNAugust 11, 1976