OPHTHALMIC TRICHIASIS PROBE

Unit, Cryophthalmic

MIRA, INC.

The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Ophthalmic Trichiasis Probe.

Pre-market Notification Details

Device IDK923629
510k NumberK923629
Device Name:OPHTHALMIC TRICHIASIS PROBE
ClassificationUnit, Cryophthalmic
Applicant MIRA, INC. 87 RUMFORD AVE. Waltham,  MA  02453 -3846
ContactRoger O'brien
CorrespondentRoger O'brien
MIRA, INC. 87 RUMFORD AVE. Waltham,  MA  02453 -3846
Product CodeHPS  
CFR Regulation Number886.4170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-21
Decision Date1992-10-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10850510007597 K923629 000

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