The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Implantech Dorsal Nasal Implant.
| Device ID | K942876 |
| 510k Number | K942876 |
| Device Name: | IMPLANTECH DORSAL NASAL IMPLANT |
| Classification | Prosthesis, Nose, Internal |
| Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Edward M Basile |
| Correspondent | Edward M Basile 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 | 1994-06-17 |
| Decision Date | 1994-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724ANI0401 | K942876 | 000 |
| M724ANI020NS1 | K942876 | 000 |
| M724ANI030NS1 | K942876 | 000 |
| M724ANI031NS1 | K942876 | 000 |
| M724ANI040NS1 | K942876 | 000 |
| M724ANI0411 | K942876 | 000 |
| M724ANI041NS1 | K942876 | 000 |
| M724ANISIZNS1 | K942876 | 000 |
| M724ANI0301 | K942876 | 000 |
| M724ANI0101 | K942876 | 000 |
| M724ANI0201 | K942876 | 000 |
| M724ANI0311 | K942876 | 000 |
| M724ANI010NS1 | K942876 | 000 |