POLAROID CONTACTSPOD

Case, Contact Lens

VIOPTI LTD

The following data is part of a premarket notification filed by Viopti Ltd with the FDA for Polaroid Contactspod.

Pre-market Notification Details

Device IDK131783
510k NumberK131783
Device Name:POLAROID CONTACTSPOD
ClassificationCase, Contact Lens
Applicant VIOPTI LTD POLAROID BLDG, VALE OF LEVEN INDUSTRIAL ESTATE Dumbarton,  GB G82 3pw
ContactEdwin Lindsay
CorrespondentEdwin Lindsay
VIOPTI LTD POLAROID BLDG, VALE OF LEVEN INDUSTRIAL ESTATE Dumbarton,  GB G82 3pw
Product CodeLRX  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-17
Decision Date2014-02-21
Summary:summary

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