The following data is part of a premarket notification filed by Spirit Ridge Technologies with the FDA for Silicone Elastomer Malar Implant.
| Device ID | K952707 |
| 510k Number | K952707 |
| Device Name: | SILICONE ELASTOMER MALAR IMPLANT |
| Classification | Prosthesis, Nose, Internal |
| Applicant | SPIRIT RIDGE TECHNOLOGIES 19325 58TH PLANCE N.E. Seattle, WA 98155 |
| Contact | Kathy Richrdson |
| Correspondent | Kathy Richrdson SPIRIT RIDGE TECHNOLOGIES 19325 58TH PLANCE N.E. Seattle, WA 98155 |
| Product Code | FZE |
| Subsequent Product Code | FWP |
| Subsequent Product Code | LZK |
| Subsequent Product Code | MIB |
| Subsequent Product Code | MIC |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-14 |
| Decision Date | 1995-08-28 |