The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Spectrum Designs Cleft Chin Implant.
| Device ID | K980461 |
| 510k Number | K980461 |
| Device Name: | SPECTRUM DESIGNS CLEFT CHIN IMPLANT |
| Classification | Prosthesis, Chin, Internal |
| 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 | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-05 |
| Decision Date | 1998-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724250634S1 | K980461 | 000 |
| M724250624S1 | K980461 | 000 |
| M724250614S1 | K980461 | 000 |
| M7249000051 | K980461 | 000 |