The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Rizzo Nasal Implant.
| Device ID | K925426 |
| 510k Number | K925426 |
| Device Name: | RIZZO NASAL IMPLANT |
| Classification | Prosthesis, Nose, Internal |
| Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Joan E Hankin |
| Correspondent | Joan E Hankin IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-27 |
| Decision Date | 1993-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724RDIXS1 | K925426 | 000 |
| M724RDIMNS1 | K925426 | 000 |
| M724RDISIZNS1 | K925426 | 000 |
| M724RDISNS1 | K925426 | 000 |
| M724RDIXLNS1 | K925426 | 000 |
| M724RDIXSNS1 | K925426 | 000 |
| M724RDIM1 | K925426 | 000 |
| M724RDIL1 | K925426 | 000 |
| M724RDIS1 | K925426 | 000 |
| M724RDIXL1 | K925426 | 000 |
| M724RDILNS1 | K925426 | 000 |