The following data is part of a premarket notification filed by Integrated Orbital Implants, Inc. with the FDA for Bio-eye Ii Orbital Implant.
| Device ID | K003338 |
| 510k Number | K003338 |
| Device Name: | BIO-EYE II ORBITAL IMPLANT |
| Classification | Implant, Eye Sphere |
| Applicant | INTEGRATED ORBITAL IMPLANTS, INC. 4329 GRAYDON RD. San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson INTEGRATED ORBITAL IMPLANTS, INC. 4329 GRAYDON RD. 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 | 2000-10-25 |
| Decision Date | 2001-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854066006120 | K003338 | 000 |
| 00854066006113 | K003338 | 000 |
| 00854066006106 | K003338 | 000 |
| 00854066006090 | K003338 | 000 |
| 00854066006083 | K003338 | 000 |
| 00854066006076 | K003338 | 000 |
| 00854066006069 | K003338 | 000 |
| 00854066006052 | K003338 | 000 |