The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Flowers Dorsal Columella Implant.
| Device ID | K904657 |
| 510k Number | K904657 |
| Device Name: | FLOWERS DORSAL COLUMELLA IMPLANT |
| Classification | Prosthesis, Nose, Internal |
| Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | M Basile |
| Correspondent | 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 | 1990-10-15 |
| Decision Date | 1990-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724VSDC0101 | K904657 | 000 |
| M724DCI03SNS1 | K904657 | 000 |
| M724VSDC001NS1 | K904657 | 000 |
| M724VSDC002NS1 | K904657 | 000 |
| M724VSDC003NS1 | K904657 | 000 |
| M724VSDC004NS1 | K904657 | 000 |
| M724VSDC010NS1 | K904657 | 000 |
| M724VSDCSIZNS1 | K904657 | 000 |
| M724VLCSIZNS1 | K904657 | 000 |
| M724VLCL1 | K904657 | 000 |
| M724VLCM1 | K904657 | 000 |
| M724VLCS1 | K904657 | 000 |
| M724DCI03F1 | K904657 | 000 |
| M724DCI03S1 | K904657 | 000 |
| M724VSDC0011 | K904657 | 000 |
| M724VSDC0021 | K904657 | 000 |
| M724VSDC0031 | K904657 | 000 |
| M724VSDC0041 | K904657 | 000 |
| M724DCI03FNS1 | K904657 | 000 |