RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000

Case, Contact Lens

APPLIED LABORATORIES, INC.

The following data is part of a premarket notification filed by Applied Laboratories, Inc. with the FDA for Red #467, #457, Blue #437, Green #447 Mindel S1000.

Pre-market Notification Details

Device IDK873824
510k NumberK873824
Device Name:RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000
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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