GE LEXAN 144R 112

Case, Contact Lens

APPLIED LABORATORIES, INC.

The following data is part of a premarket notification filed by Applied Laboratories, Inc. with the FDA for Ge Lexan 144r 112.

Pre-market Notification Details

Device IDK873825
510k NumberK873825
Device Name:GE LEXAN 144R 112
ClassificationCase, Contact Lens
Applicant APPLIED LABORATORIES, INC. 3360 COMMERCE PARK DR. Columbus,  IN  47201
ContactAnthony J Moravec
CorrespondentAnthony J Moravec
APPLIED LABORATORIES, INC. 3360 COMMERCE PARK DR. Columbus,  IN  47201
Product CodeLRX  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-21
Decision Date1988-03-24

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