The following data is part of a premarket notification filed by Oculab, Inc. with the FDA for Ocu-film Tip Cover.
| Device ID | K882750 |
| 510k Number | K882750 |
| Device Name: | OCU-FILM TIP COVER |
| Classification | Tonometer, Manual |
| Applicant | OCULAB, INC. 443 WEST COLORADO ST. Gendale, CA 91204 |
| Contact | Bruce Burr |
| Correspondent | Bruce Burr OCULAB, INC. 443 WEST COLORADO ST. Gendale, CA 91204 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-05 |
| Decision Date | 1988-08-04 |