HRG · Class I · 21 CFR 886.4070

FDA Product Code HRG: Engine, Trephine, Accessories, Ac-powered

Leading manufacturers include Edward Weck, Inc., Scanlan Intl., Inc. and Laser Center Dev. Corp..

6
Total
6
Cleared
101d
Avg days
1979
Since

FDA 510(k) Cleared Engine, Trephine, Accessories, Ac-powered Devices (Product Code HRG)

6 devices
1–6 of 6
Cleared Jun 23, 1998
AUTOMATED CORNEAL TREPHINE
K981063
Laser Center Dev. Corp.
Ophthalmic · 92d
Cleared Jun 05, 1984
SCANLAN VASCU-STATT II
K841515
Scanlan Intl., Inc.
Ophthalmic · 54d
Cleared Jan 17, 1983
TREPHINE BLADES-VARIOUS MODELS
K823901
Edward Weck, Inc.
Ophthalmic · 18d

About Product Code HRG - Regulatory Context