The following data is part of a premarket notification filed by Oculo Plastik, Inc. with the FDA for Eye Sphere Implants.
| Device ID | K040689 |
| 510k Number | K040689 |
| Device Name: | EYE SPHERE IMPLANTS |
| Classification | Implant, Eye Sphere |
| Applicant | OCULO PLASTIK, INC. 200 SAUVE WEST Montreal, Quebec, CA H3l 1y9 |
| Contact | Jean-francois Drette |
| Correspondent | Jean-francois Drette OCULO PLASTIK, INC. 200 SAUVE WEST Montreal, Quebec, 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 | 2004-03-16 |
| Decision Date | 2004-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M8721132203 | K040689 | 000 |
| M8721131808 | K040689 | 000 |
| 10697660000333 | K040689 | 000 |
| M8721131404 | K040689 | 000 |
| 10697660000319 | K040689 | 000 |