The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Spectrum Designs Profile Malar Implant.
| Device ID | K980139 |
| 510k Number | K980139 |
| Device Name: | SPECTRUM DESIGNS PROFILE 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 |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-15 |
| Decision Date | 1998-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724140444S1 | K980139 | 000 |
| M724140434S1 | K980139 | 000 |
| M724140424S1 | K980139 | 000 |
| M724140414S1 | K980139 | 000 |
| M7249000141 | K980139 | 000 |