The following data is part of a premarket notification filed by Laser Center Dev. Corp. with the FDA for Automated Corneal Trephine.
Device ID | K981063 |
510k Number | K981063 |
Device Name: | AUTOMATED CORNEAL TREPHINE |
Classification | Engine, Trephine, Accessories, Ac-powered |
Applicant | LASER CENTER DEV. CORP. 1028 S. KIRKWOOD RD. SUITE A St. Louis, MO 63122 -7222 |
Contact | Francis E O'donnell, Jr. |
Correspondent | Francis E O'donnell, Jr. LASER CENTER DEV. CORP. 1028 S. KIRKWOOD RD. SUITE A St. Louis, MO 63122 -7222 |
Product Code | HRG |
CFR Regulation Number | 886.4070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-23 |
Decision Date | 1998-06-23 |
Summary: | summary |