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 |