FMW · Class I · 21 CFR 880.6190

FDA Product Code FMW: Cover, Mattress (medical Purposes)

Leading manufacturers include Precision Fabrics Group, Inc., American Threshold Industries, Inc. and Mallinckrodt Group, Inc..

14
Total
14
Cleared
168d
Avg days
1978
Since

FDA 510(k) Cleared Cover, Mattress (medical Purposes) Devices (Product Code FMW)

14 devices
1–14 of 14
Cleared Jun 20, 2016
DermaTherapy Bed Linens
K152884
Precision Fabrics Group, Inc.
General Hospital · 264d
Cleared Jan 25, 2007
DERMATHERAPY, MODEL 22216
K061242
Precision Fabrics Group, Inc.
General Hospital · 267d
Cleared Nov 08, 1999
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
K992702
Allergy Direct
General Hospital · 88d
Cleared Feb 25, 1994
INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
K940327
W.L. Gore & Associates, Inc.
General Hospital · 32d
Cleared Aug 10, 1990
DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST
K902446
Mallinckrodt Group, Inc.
General Hospital · 70d
Cleared Feb 04, 1984
MATTRESS COVER, ANTI-MICROBIAL
K832483
American Threshold Industries, Inc.
General Hospital · 194d

About Product Code FMW - Regulatory Context