510(k) K944165 ยท LZK Implant, Malar
SILHOUETTE MALAR IMPLANT
| Applicant | Spectrum Designs, Inc., Goleta CA, US |
| Decision | Substantially Equivalent, Nov 4, 1994 |
| Received | Aug 26, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944165
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2007 | Spectrum Designs Inc Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S. Terminated |
LZK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.