ENDOPHOTOCOAGULATION PROBE

Laser, Ophthalmic

MIRA, INC.

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

Pre-market Notification Details

Device IDK863591
510k NumberK863591
Device Name:ENDOPHOTOCOAGULATION PROBE
ClassificationLaser, Ophthalmic
Applicant MIRA, INC. 87 RUMFORD AVE. Waltham,  MA  02453 -3846
ContactMark W Furlong
CorrespondentMark W Furlong
MIRA, INC. 87 RUMFORD AVE. Waltham,  MA  02453 -3846
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-15
Decision Date1986-10-10

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