The following data is part of a premarket notification filed by Integrated Orbital Implants, Inc. with the FDA for Bio-eye Hydroxyapatite Ocular Impland And Conformer.
| Device ID | K982562 |
| 510k Number | K982562 |
| Device Name: | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER |
| Classification | Implant, Eye Sphere |
| Applicant | INTEGRATED ORBITAL IMPLANTS, INC. 12526 HIGH BLUFF DR. SUITE 300 San Diego, CA 92130 |
| Contact | Jeanne Dunham |
| Correspondent | Jeanne Dunham INTEGRATED ORBITAL IMPLANTS, INC. 12526 HIGH BLUFF DR. SUITE 300 San Diego, CA 92130 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-23 |
| Decision Date | 1998-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854066006045 | K982562 | 000 |
| 00854066006038 | K982562 | 000 |
| 00854066006021 | K982562 | 000 |
| 00854066006014 | K982562 | 000 |
| 00854066006007 | K982562 | 000 |