The following data is part of a premarket notification filed by Oculo Plastik, Inc. with the FDA for Spivey-allen Orbital Floor Implant.
| Device ID | K900930 |
| 510k Number | K900930 |
| Device Name: | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT |
| 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 | 1990-02-27 |
| Decision Date | 1990-05-15 |