The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Silhouette Malar Implant.
| Device ID | K944165 |
| 510k Number | K944165 |
| Device Name: | SILHOUETTE MALAR 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 |
|---|---|---|
| M724160634S1 | K944165 | 000 |
| M724160624S1 | K944165 | 000 |
| M724160614S1 | K944165 | 000 |
| M724120234S1 | K944165 | 000 |
| M724120224S1 | K944165 | 000 |
| M724120214S1 | K944165 | 000 |
| M7249000131 | K944165 | 000 |
| M7249000101 | K944165 | 000 |