CORNEAL LIGHT SHIELD

Microscope, Operating & Accessories, Ac-powered, Ophthalmic

MENTOR O & O, INC.

The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Corneal Light Shield.

Pre-market Notification Details

Device IDK850270
510k NumberK850270
Device Name:CORNEAL LIGHT SHIELD
ClassificationMicroscope, Operating & Accessories, Ac-powered, Ophthalmic
Applicant MENTOR O & O, INC. SOUTH SHORE PARK Hingham,  MA  02043
ContactDavid M Link
CorrespondentDavid M Link
MENTOR O & O, INC. SOUTH SHORE PARK Hingham,  MA  02043
Product CodeHRM  
CFR Regulation Number878.4700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-23
Decision Date1985-05-31

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