RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (other Material) - Daily

POLYMER TECHNOLOGY

The following data is part of a premarket notification filed by Polymer Technology with the FDA for Rigid Gas Permeable Contact Lens.

Pre-market Notification Details

Device IDK000795
510k NumberK000795
Device Name:RIGID GAS PERMEABLE CONTACT LENS
ClassificationLens, Contact (other Material) - Daily
Applicant POLYMER TECHNOLOGY 1400 N GOODMAN ST. Rochester,  NY  14692
ContactDebra L.b. Ketchum
CorrespondentDebra L.b. Ketchum
POLYMER TECHNOLOGY 1400 N GOODMAN ST. Rochester,  NY  14692
Product CodeHQD  
CFR Regulation Number886.5916 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-13
Decision Date2000-05-26
Summary:summary

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