MODIFIED DEVICE FOR SELF EXAMINATION OF EYES

Grid, Amsler

WHEEL CHECKERS

The following data is part of a premarket notification filed by Wheel Checkers with the FDA for Modified Device For Self Examination Of Eyes.

Pre-market Notification Details

Device IDK863429
510k NumberK863429
Device Name:MODIFIED DEVICE FOR SELF EXAMINATION OF EYES
ClassificationGrid, Amsler
Applicant WHEEL CHECKERS 2020 SOUTH BANNOCK STREET Denver ,  CO  80223 -
ContactGieskieng
CorrespondentGieskieng
WHEEL CHECKERS 2020 SOUTH BANNOCK STREET Denver ,  CO  80223 -
Product CodeHOQ  
CFR Regulation Number886.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-04
Decision Date1987-01-20

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