OMS QUARTZ INFUSION CONTACT LENS

Lens, Fundus, Hruby, Diagnostic

OPTICAL MICRO SYSTEMS, INC.

The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Oms Quartz Infusion Contact Lens.

Pre-market Notification Details

Device IDK820223
510k NumberK820223
Device Name:OMS QUARTZ INFUSION CONTACT LENS
ClassificationLens, Fundus, Hruby, Diagnostic
Applicant OPTICAL MICRO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHJI  
CFR Regulation Number886.1395 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-27
Decision Date1982-02-05

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