PLASTIC OVERLAYS

Prism, Bar, Ophthalmic

NATIONAL READING SERVICE

The following data is part of a premarket notification filed by National Reading Service with the FDA for Plastic Overlays.

Pre-market Notification Details

Device IDK911374
510k NumberK911374
Device Name:PLASTIC OVERLAYS
ClassificationPrism, Bar, Ophthalmic
Applicant NATIONAL READING SERVICE 2104 S.W. ADAMS ST. PEORIA,  IL  61602
ContactSUMNER BORIN
CorrespondentSUMNER BORIN
NATIONAL READING SERVICE 2104 S.W. ADAMS ST. PEORIA,  IL  61602
Product CodeHKW  
CFR Regulation Number886.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-28
Decision Date1991-07-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.