The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Implantech Dorsal Columella Implant Style Ii.
| Device ID | K941960 |
| 510k Number | K941960 |
| Device Name: | IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II |
| 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 | 1994-04-22 |
| Decision Date | 1994-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724SNIL11 | K941960 | 000 |
| M724SNIL1PAK1 | K941960 | 000 |
| M724SNIL1NS1 | K941960 | 000 |