OPTIKEM PMMA CONTACT LENS

Lens, Contact (polymethylmethacrylate)

OPTIKEM POLYMERS, INC.

The following data is part of a premarket notification filed by Optikem Polymers, Inc. with the FDA for Optikem Pmma Contact Lens.

Pre-market Notification Details

Device IDK895411
510k NumberK895411
Device Name:OPTIKEM PMMA CONTACT LENS
ClassificationLens, Contact (polymethylmethacrylate)
Applicant OPTIKEM POLYMERS, INC. 2890 SOUTH TEJON ST. Englewood,  CO  80110
ContactWilliam Hoffman
CorrespondentWilliam Hoffman
OPTIKEM POLYMERS, INC. 2890 SOUTH TEJON ST. Englewood,  CO  80110
Product CodeHPX  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-06
Decision Date1990-02-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858174006003 K895411 000

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