FME · Class I · 21 CFR 880.6265

FDA Product Code FME: Gown, Examination

Leading manufacturers include American Hospital Supply Corp. and Kimberly-Clark Corp..

5
Total
5
Cleared
48d
Avg days
1976
Since

FDA 510(k) Cleared Gown, Examination Devices (Product Code FME)

5 devices
1–5 of 5
Cleared Feb 19, 1988
KIMBERLY-CLARK PROFESSIONAL JACKET
K880385
Kimberly-Clark Corp.
General Hospital · 22d
Cleared Jul 28, 1981
MONITOR/VITAL SIGNS TRAY
K811915
American Hospital Supply Corp.
General Hospital · 27d

About Product Code FME - Regulatory Context