The following data is part of a premarket notification filed by Applied Biomaterial Technologies with the FDA for The Nautilus Nasal Implant.
| Device ID | K902283 |
| 510k Number | K902283 |
| Device Name: | THE NAUTILUS NASAL IMPLANT |
| Classification | Prosthesis, Nose, Internal |
| Applicant | APPLIED BIOMATERIAL TECHNOLOGIES 851 SIXTH ST. S#145 BREMERTON, WA 98310 |
| Contact | GERALD L HANSON |
| Correspondent | GERALD L HANSON APPLIED BIOMATERIAL TECHNOLOGIES 851 SIXTH ST. S#145 BREMERTON, WA 98310 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-22 |
| Decision Date | 1990-08-14 |