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KME — Bedding, Disposable, Medical Class I

FDA Device Classification

Classification Details

Product Code
KME
Device Class
Class I
Regulation Number
880.6060
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K042145techtradeREADY-HEAT BLANKETSeptember 17, 2004
K944953thantex specialtiesOREX MEDICAL BEDDINGDecember 2, 1994
K933636belmac healthcareDISPOSE-A-SHEETJanuary 26, 1994
K932539three dog downDOCTOR DOWN --RESCUE WRAPNovember 2, 1993
K922143american silk suturesAMERICAN BURN SHEETAugust 10, 1992
K915303gam industriesFOIL BABY BUNTINGFebruary 20, 1992
K912257haz-medCHEM-SLEEVE BDecember 31, 1991
K911953sancellaMEDI GUARD SHEETS/UNDERLAYSMay 28, 1991
K911948sancellaMEDI GUARD PILLOWCASEMay 28, 1991
K911952sancellaMEDI GUARD UNDERPADMay 28, 1991
K911950sancellaMEDI GUARD DRAPESMay 21, 1991
K905003network medical systemsBIO-GUARD SHAVE PREP TRAYDecember 28, 1990
K904274anagoRECEIVING BLANKETOctober 26, 1990
K901509haz-medTRAUMA SLEEVESeptember 12, 1990
K901629haz-medCHEM-SLEEVEApril 27, 1990
K900643infection control productsFLUID SOAKERSHIELDApril 25, 1990
K896043keystone veterinary suppliesMATTRESS COVER FOR MEDICAL PURPOSESJanuary 10, 1990
K891986mark one healthcare productsMULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCEDecember 29, 1989
K894170devon industriesDEVON DISPOSABLE HEAD POSITIONER COVERSeptember 7, 1989
K884380saybrex intlBED SHEET, PILLOW CASENovember 8, 1988