OPTIMUM GP (roflufocon D, Roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

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 (roflufocon D, Roflurocon E) Daily Wear Contact Lens, Hexa100 (hexafocon A) Daily Wear Contact Lens.

Pre-market Notification Details

Device IDK180616
510k NumberK180616
Device Name:OPTIMUM GP (roflufocon D, Roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
ClassificationLens, Contact (other Material) - Daily
Applicant Contamac Ltd. Carlton House Shire Hall 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 Received2018-03-08
Decision Date2018-04-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865576000287 K180616 000

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