SUNGLASSES

Sunglasses (non-prescription Including Photosensitive)

EYE DEALS

The following data is part of a premarket notification filed by Eye Deals with the FDA for Sunglasses.

Pre-market Notification Details

Device IDK953260
510k NumberK953260
Device Name:SUNGLASSES
ClassificationSunglasses (non-prescription Including Photosensitive)
Applicant EYE DEALS 828 HAZELWOOD AVE. Pittsburgh,  PA  15217
ContactSamuel R Shapiro
CorrespondentSamuel R Shapiro
EYE DEALS 828 HAZELWOOD AVE. Pittsburgh,  PA  15217
Product CodeHQY  
CFR Regulation Number886.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-12
Decision Date1995-07-19

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