The following data is part of a premarket notification filed by Laboratoire Villanova with the FDA for Ha Orbital Implant.
| Device ID | K021643 |
| 510k Number | K021643 |
| Device Name: | HA ORBITAL IMPLANT |
| Classification | Implant, Eye Sphere |
| Applicant | LABORATOIRE VILLANOVA RESIDENCE BLUE MARINE 65 RUE LEON GARET Le Touquet, FR F62520 |
| Contact | Isabelle Drubaix |
| Correspondent | Isabelle Drubaix LABORATOIRE VILLANOVA RESIDENCE BLUE MARINE 65 RUE LEON GARET Le Touquet, FR F62520 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-20 |
| Decision Date | 2002-12-13 |
| Summary: | summary |