The following data is part of a premarket notification filed by Phakos with the FDA for Mira Adapter.
Device ID | K200911 |
510k Number | K200911 |
Device Name: | MIRA Adapter |
Classification | Unit, Cryophthalmic, Ac-powered |
Applicant | Phakos 62 Rue Kléber Montreuil, FR 93100 |
Contact | Olivier Aumaitre |
Correspondent | J.d. Webb The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, UT 84401 |
Product Code | HRN |
CFR Regulation Number | 886.4170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-06 |
Decision Date | 2020-06-02 |