The following data is part of a premarket notification filed by Oculo Plastik, Inc. with the FDA for Ophtimplant.
| Device ID | K915630 |
| 510k Number | K915630 |
| Device Name: | OPHTIMPLANT |
| Classification | Implant, Eye Sphere |
| Applicant | OCULO PLASTIK, INC. 1170 EAST HENRI-BOURASSA BLVD. Montreal, Quebec Canada, CA H2c 1g4 |
| Contact | Durette |
| Correspondent | Durette OCULO PLASTIK, INC. 1170 EAST HENRI-BOURASSA BLVD. Montreal, Quebec Canada, CA H2c 1g4 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-17 |
| Decision Date | 1992-03-02 |