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 |