KME · Class I · 21 CFR 880.6060

FDA Product Code KME: Bedding, Disposable, Medical

Leading manufacturers include Sancella, Inc., Kimberly-Clark Corp. and Haz-Med, Inc..

65
Total
65
Cleared
58d
Avg days
1976
Since
65 devices
49–65 of 65
Cleared Aug 04, 1981
DISPOSABLE PILLOW
K812079
Carpenter Co.
General Hospital · 13d
Cleared May 21, 1981
DISPOSABLE UNDERPADS
K811232
Burina
General Hospital · 17d
Cleared Feb 09, 1981
DISPOSABLE PILLOW
K810264
Anago, Inc.
General Hospital · 7d
Cleared Dec 22, 1980
PATIENT CARE DISPOSABLE INFANT SHIRTS
K802998
American Convertors Div., American Pharmaseal
General Hospital · 27d
Cleared Jan 16, 1980
STERILIZATION PROCESS/BABY BLANKET
K792626
Procter & Gamble Mfg. Co.
General Hospital · 28d
Cleared Jun 01, 1979
AUTO TRAUMA KIT
K790411
Marshall Electronics, Inc.
General Hospital · 95d
Cleared Apr 30, 1979
INFANT SCALE DISPOSABLE LINER
K790659
Hydro-Med Products, Inc.
General Hospital · 26d
Cleared Apr 06, 1979
PILLOW, CARTER ARM ELEVATION
K790283
Depuy, Inc.
General Hospital · 52d
Cleared Dec 07, 1978
BEDDING, DISPOSABLE HOSPITAL
K781796
Kimberly-Clark Corp.
General Hospital · 43d
Cleared Dec 07, 1978
ROSEALAE
K782001
Asmb
General Hospital · 3d
Cleared Oct 17, 1978
TOWELS, SHEETS, PILLOWCASES
K781227
Abco Dealers, Inc.
General Hospital · 91d
Cleared Oct 17, 1978
PILLOWS- SINGLE PATIENT USE
K781354
Abco Dealers, Inc.
General Hospital · 70d
Cleared Apr 29, 1977
SHEET KIT, STRETCHER, DISPOSABLE
K770486
American Hospital Supply Corp.
General Hospital · 46d
Cleared Dec 02, 1976
PLASTIC DISPOSABLE BIB
K761108
Fred Sammons, Inc.
General Hospital · 13d
Cleared Dec 02, 1976
TERRYCLOTH BIBS
K761109
Fred Sammons, Inc.
General Hospital · 13d