The following data is part of a premarket notification filed by Omni Intl., Inc. with the FDA for F-series Implant.
| Device ID | K850706 |
| 510k Number | K850706 |
| Device Name: | F-SERIES IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OMNI INTL., INC. 1100 N. FLORIDA AVENUE Tampa , FL 33602 - |
| Contact | Robert M Hatfield |
| Correspondent | Robert M Hatfield OMNI INTL., INC. 1100 N. FLORIDA AVENUE Tampa , FL 33602 - |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-22 |
| Decision Date | 1985-04-10 |