Optimum GP With HPT (roflufocon A, B, C, D, And E) Daily Wear Contact Lenses

Lens, Contact (other Material) - Daily

CONTAMAC LTD.

The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Optimum Gp With Hpt (roflufocon A, B, C, D, And E) Daily Wear Contact Lenses.

Pre-market Notification Details

Device IDK161100
510k NumberK161100
Device Name:Optimum GP With HPT (roflufocon A, B, C, D, And E) Daily Wear Contact Lenses
ClassificationLens, Contact (other Material) - Daily
Applicant CONTAMAC LTD. CARLTON HOUSE SHIRE HILL Saffron Walden,  GB Cb11 3au
ContactRob Mcgregor
CorrespondentBret Andre
EYEREG CONSULTING, INC. 6119 CANTER LN West Linn,  OR  97068
Product CodeHQD  
CFR Regulation Number886.5916 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-19
Decision Date2016-08-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865576000225 K161100 000
00865576000218 K161100 000
00865576000201 K161100 000

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