The following data is part of a premarket notification filed by Oculo Plastik, Inc. with the FDA for O'donnell, Socket Reconstruction Prostheses.
| Device ID | K901002 |
| 510k Number | K901002 |
| Device Name: | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES |
| Classification | Implant, Orbital, Extra-ocular |
| Applicant | OCULO PLASTIK, INC. 1170 EAST HENRI-BOURASSA BLVD. Montreal, Quebec Canada, CA H2c 1g4 |
| Contact | Jean-francois Durett |
| Correspondent | Jean-francois Durett OCULO PLASTIK, INC. 1170 EAST HENRI-BOURASSA BLVD. Montreal, Quebec Canada, CA H2c 1g4 |
| Product Code | HQX |
| CFR Regulation Number | 886.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-02 |
| Decision Date | 1990-05-22 |