The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Flowers Nasal Implant.
| Device ID | K904656 |
| 510k Number | K904656 |
| Device Name: | FLOWERS NASAL 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 |
|---|---|---|
| M724SLUP081 | K904656 | 000 |
| M724SLUP06NS1 | K904656 | 000 |
| M724SLUP05NS1 | K904656 | 000 |
| M724SLUP04NS1 | K904656 | 000 |
| M724SLUP03NS1 | K904656 | 000 |
| M724SLUP02NS1 | K904656 | 000 |
| M724SLUP01NS1 | K904656 | 000 |
| M724FDISIZNS1 | K904656 | 000 |
| M724FDI45NS1 | K904656 | 000 |
| M724FDI35NS1 | K904656 | 000 |
| M724FDI25NS1 | K904656 | 000 |
| M724SLUP07NS1 | K904656 | 000 |
| M724SLUP08NS1 | K904656 | 000 |
| M724FDI351 | K904656 | 000 |
| M724SLUP071 | K904656 | 000 |
| M724SLUP061 | K904656 | 000 |
| M724SLUP051 | K904656 | 000 |
| M724SLUP031 | K904656 | 000 |
| M724FDI451 | K904656 | 000 |
| M724FDI251 | K904656 | 000 |
| M724FDI151 | K904656 | 000 |
| M724SLUP041 | K904656 | 000 |
| M724SLUP021 | K904656 | 000 |
| M724SLUP011 | K904656 | 000 |
| M724FDI15NS1 | K904656 | 000 |