The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Dorsal Columella Implant.
| Device ID | K944166 |
| 510k Number | K944166 |
| Device Name: | DORSAL COLUMELLA IMPLANT |
| Classification | Implant, Malar |
| Applicant | SPECTRUM DESIGNS, INC. 5921-C MATTHEWS ST. Goleta, CA 93117 |
| Contact | Jim Dishman |
| Correspondent | Jim Dishman SPECTRUM DESIGNS, INC. 5921-C MATTHEWS ST. Goleta, CA 93117 |
| Product Code | LZK |
| Subsequent Product Code | FWP |
| Subsequent Product Code | FZE |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1994-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724400824S1 | K944166 | 000 |
| M724400514S1 | K944166 | 000 |
| M724400414S1 | K944166 | 000 |
| M724400314S1 | K944166 | 000 |
| M724400214S1 | K944166 | 000 |
| M724400114S1 | K944166 | 000 |
| M7249000221 | K944166 | 000 |
| M7249000211 | K944166 | 000 |
| M7249000201 | K944166 | 000 |
| M7249000191 | K944166 | 000 |
| M7249000181 | K944166 | 000 |
| M7249000171 | K944166 | 000 |
| M7249000161 | K944166 | 000 |
| M724400524S1 | K944166 | 000 |
| M724400534S1 | K944166 | 000 |
| M724400544S1 | K944166 | 000 |
| M724400814S1 | K944166 | 000 |
| M724400754S1 | K944166 | 000 |
| M724400744S1 | K944166 | 000 |
| M724400734S1 | K944166 | 000 |
| M724400724S1 | K944166 | 000 |
| M724400714S1 | K944166 | 000 |
| M724400664S1 | K944166 | 000 |
| M724400654S1 | K944166 | 000 |
| M724400644S1 | K944166 | 000 |
| M724400634S1 | K944166 | 000 |
| M724400624S1 | K944166 | 000 |
| M724400614S1 | K944166 | 000 |
| M7249000151 | K944166 | 000 |