OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) 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 Hr-1.51 (hiflufocon A) And Hr-1.53 (hiflufocon B) Daily Wear Contact Lenses.

Pre-market Notification Details

Device IDK081178
510k NumberK081178
Device Name:OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
ClassificationLens, Contact (other Material) - Daily
Applicant CONTAMAC LTD. 806 KIMBALL AVENUE Grand Junction,  CO  81501
ContactMartin Dalsing
CorrespondentMartin Dalsing
CONTAMAC LTD. 806 KIMBALL AVENUE Grand Junction,  CO  81501
Product CodeHQD  
CFR Regulation Number886.5916 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-25
Decision Date2008-10-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865576000256 K081178 000
00865576000249 K081178 000

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