HRK · Class I · 21 CFR 886.4855

FDA Product Code HRK: Table, Instrument, Manual, Ophthalmic

Leading manufacturers include Alcon Laboratories and American Edwards Laboratories.

2
Total
2
Cleared
90d
Avg days
1976
Since

FDA 510(k) Cleared Table, Instrument, Manual, Ophthalmic Devices (Product Code HRK)

2 devices
1–2 of 2
Cleared Nov 05, 1984
AMER. EDWARDS LAB FLEXISCOPE
K842410
American Edwards Laboratories
Ophthalmic · 139d
Cleared Nov 02, 1976
EVANS ARM AND HAND REST
K760697
Alcon Laboratories
Ophthalmic · 41d

About Product Code HRK - Regulatory Context