The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Monarch Nasal Implant.
| Device ID | K041690 |
| 510k Number | K041690 |
| Device Name: | MONARCH NASAL IMPLANT |
| Classification | Prosthesis, Nose, Internal |
| Applicant | HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346 |
| Contact | Gerald Hanson |
| Correspondent | Gerald Hanson HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-22 |
| Decision Date | 2005-02-11 |
| Summary: | summary |