The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Solid Dilicone Implants, Sdilicone Sponge Implants.
| Device ID | K950806 |
| 510k Number | K950806 |
| Device Name: | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS |
| Classification | Implant, Orbital, Extra-ocular |
| Applicant | MIRA, INC. 414 QUAKER HWY. Uxbridge, MA 01569 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson MIRA, INC. 414 QUAKER HWY. Uxbridge, MA 01569 |
| Product Code | HQX |
| CFR Regulation Number | 886.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-22 |
| Decision Date | 1996-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850510007009 | K950806 | 000 |
| 20850510007136 | K950806 | 000 |
| 20850510007143 | K950806 | 000 |
| 20850510007167 | K950806 | 000 |
| 20850510007174 | K950806 | 000 |
| 20850510007181 | K950806 | 000 |
| 20850510007198 | K950806 | 000 |
| 20850510007204 | K950806 | 000 |
| 20850510007211 | K950806 | 000 |
| 10850510007122 | K950806 | 000 |
| 20850510007112 | K950806 | 000 |
| 20850510007105 | K950806 | 000 |
| 20850510007013 | K950806 | 000 |
| 10850510007023 | K950806 | 000 |
| 20850510007037 | K950806 | 000 |
| 20850510007044 | K950806 | 000 |
| 20850510007051 | K950806 | 000 |
| 10850510007078 | K950806 | 000 |
| 10850510007085 | K950806 | 000 |
| 20850510007099 | K950806 | 000 |
| 20850510007228 | K950806 | 000 |
| 20850510007235 | K950806 | 000 |
| 20850510007242 | K950806 | 000 |
| 20850510007365 | K950806 | 000 |
| 20850510007372 | K950806 | 000 |
| 20850510007389 | K950806 | 000 |
| 20850510007396 | K950806 | 000 |
| 20850510007402 | K950806 | 000 |
| 20850510007419 | K950806 | 000 |
| 20850510007426 | K950806 | 000 |
| 20850510007433 | K950806 | 000 |
| 20850510007358 | K950806 | 000 |
| 20850510007341 | K950806 | 000 |
| 20850510007334 | K950806 | 000 |
| 20850510007259 | K950806 | 000 |
| 20850510007266 | K950806 | 000 |
| 20850510007273 | K950806 | 000 |
| 20850510007280 | K950806 | 000 |
| 20850510007297 | K950806 | 000 |
| 20850510007303 | K950806 | 000 |
| 20850510007310 | K950806 | 000 |
| 10850510007320 | K950806 | 000 |
| 20850510007440 | K950806 | 000 |