FOK · Class I · 21 CFR 880.5270

FDA Product Code FOK: Pad, Neonatal Eye

Leading manufacturers include Graphic Controls Corp. and Debusk Technology Corp..

5
Total
5
Cleared
42d
Avg days
1981
Since

FDA 510(k) Cleared Pad, Neonatal Eye Devices (Product Code FOK)

5 devices
1–5 of 5
Cleared Jul 03, 1996
DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
K962290
Debusk Technology Corp.
General Hospital · 19d
Cleared Mar 15, 1993
LIFE TRACE(R) BILIRUBIN MASK
K926118
Graphic Controls Corp.
General Hospital · 102d

About Product Code FOK - Regulatory Context