510(k) K944166 ยท LZK Implant, Malar
DORSAL COLUMELLA 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 K944166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2007 | Spectrum Designs Inc Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655 Terminated |
LZK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.