ITG — Bandage, Cast Class I

FDA Device Classification

Classification Details

Product Code
ITG
Device Class
Class I
Regulation Number
890.3025
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K873111kendalCONFORMA(TM) PLASTER BANDAGESOctober 9, 1987
K862115deknatelDEKNA BAND KITAugust 19, 1986
K842573poly groupT.P.G. CAST TAPEAugust 10, 1984
K840416hexcel medicalHEXCELITEMarch 23, 1984
K833732american medical disposableNON WETTING UNDERCAST PADDINGDecember 12, 1983
K832992smith and nephewSOFFBAN ORTHOPEDIC PADDINGNovember 14, 1983
K832237cutter laboratoriesORTHOPEDIC CASTING TAPE MAXCASTAugust 16, 1983
K830650isopedixSUPPORT PRODUCTS EXAMPLE PROSET CASTJuly 7, 1983
K831492watson phillips y cia. sucs., s.a. de c.vYESONA PLASTER OF PARIS BANDAGEJune 30, 1983
K820890hexcel medicalURETHANE ORTHOPAEDIC CASTING TAPEJune 23, 1982
K820140stan-pak entWEBRIL CAST PADDINGFebruary 12, 1982
K820155stan-pak entSPECIALIST CAST PADDINGFebruary 12, 1982
K813052zimmerULTRACAST WATERLESS SYNTHETIC RESIN CASTFebruary 4, 1982
K813219carapaceCARAFLEX ELASTIC POLYMER PLASTER BANDADecember 17, 1981
K811754smith and nephewCRYSTONAJuly 20, 1981
K811164hexcel medicalURETHANE ORTHOPAEDIC CASTING TAPEMay 27, 1981
K810877ortho-castORTHOSIS BANDAGESApril 17, 1981
K810111secolCELLONA PLASTER VARNISHFebruary 4, 1981
K802792secolCELLONADecember 10, 1980
K802796secolCELLAMINNovember 24, 1980