MIRA Adapter

Unit, Cryophthalmic, Ac-powered

Phakos

The following data is part of a premarket notification filed by Phakos with the FDA for Mira Adapter.

Pre-market Notification Details

Device IDK200911
510k NumberK200911
Device Name:MIRA Adapter
ClassificationUnit, Cryophthalmic, Ac-powered
Applicant Phakos 62 Rue Kléber Montreuil,  FR 93100
ContactOlivier Aumaitre
CorrespondentJ.d. Webb
The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven,  UT  84401
Product CodeHRN  
CFR Regulation Number886.4170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-06
Decision Date2020-06-02

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