The following data is part of a premarket notification filed by Evera Medical, Inc. with the FDA for Orbital Reconstructive Implant Ii.
| Device ID | K083342 |
| 510k Number | K083342 |
| Device Name: | ORBITAL RECONSTRUCTIVE IMPLANT II |
| Classification | Implant, Eye Sphere |
| Applicant | EVERA MEDICAL, INC. 353 VINTAGE PARK DRIVE SUITE F Foster City, CA 94404 |
| Contact | Randy Kesten |
| Correspondent | Randy Kesten EVERA MEDICAL, INC. 353 VINTAGE PARK DRIVE SUITE F Foster City, CA 94404 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-12 |
| Decision Date | 2009-03-12 |
| Summary: | summary |