The following data is part of a premarket notification filed by Laser Center Dev. Corp. with the FDA for Oculostat.
| Device ID | K981235 |
| 510k Number | K981235 |
| Device Name: | OCULOSTAT |
| Classification | Specula, Ophthalmic |
| Applicant | LASER CENTER DEV. CORP. 1028 S. KIRKWOOD RD. SUITE A St. Louis, MO 63122 -7222 |
| Contact | Francis E O'donnell |
| Correspondent | Francis E O'donnell LASER CENTER DEV. CORP. 1028 S. KIRKWOOD RD. SUITE A St. Louis, MO 63122 -7222 |
| Product Code | HNC |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-03 |
| Decision Date | 1998-07-15 |
| Summary: | summary |