The following data is part of a premarket notification filed by Oculo-plastik, Inc. with the FDA for Durette Ocular Implant.
| Device ID | K123764 |
| 510k Number | K123764 |
| Device Name: | DURETTE OCULAR IMPLANT |
| Classification | Implant, Eye Sphere |
| Applicant | OCULO-PLASTIK, INC. 200, RUE SAUVE OUEST Montreal, Qc, CA H3l 1y9 |
| Contact | Sylvain Desrosiers |
| Correspondent | Sylvain Desrosiers OCULO-PLASTIK, INC. 200, RUE SAUVE OUEST Montreal, Qc, CA H3l 1y9 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-07 |
| Decision Date | 2013-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M8721242003 | K123764 | 000 |
| M8721212000 | K123764 | 000 |