RX LENS SERIES

Lens, Spectacle, Non-custom (prescription)

GENTEX CORPORATION

The following data is part of a premarket notification filed by Gentex Corporation with the FDA for Rx Lens Series.

Pre-market Notification Details

Device IDK772024
510k NumberK772024
Device Name:RX LENS SERIES
ClassificationLens, Spectacle, Non-custom (prescription)
Applicant GENTEX CORPORATION 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHQG  
CFR Regulation Number886.5844 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-10-26
Decision Date1977-11-09

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