The following data is part of a premarket notification filed by Becker & Associates Consulting Inc with the FDA for Orbital Reconstructive Implant.
| Device ID | K070130 |
| 510k Number | K070130 |
| Device Name: | ORBITAL RECONSTRUCTIVE IMPLANT |
| Classification | Implant, Eye Sphere |
| Applicant | BECKER & ASSOCIATES CONSULTING INC 2001 PENNSYLVANIA AVENUE NW SUITE 950 Washington, DC 20006 |
| Contact | Campbell Tuskey |
| Correspondent | Campbell Tuskey BECKER & ASSOCIATES CONSULTING INC 2001 PENNSYLVANIA AVENUE NW SUITE 950 Washington, DC 20006 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-04-19 |
| Summary: | summary |