VASSEN COLOR

Lenses, Soft Contact, Daily Wear

VASSEN CO., LTD.

The following data is part of a premarket notification filed by Vassen Co., Ltd. with the FDA for Vassen Color.

Pre-market Notification Details

Device IDK141699
510k NumberK141699
Device Name:VASSEN COLOR
ClassificationLenses, Soft Contact, Daily Wear
Applicant VASSEN CO., LTD. 474 NE 61ST PL. Hillsboro,  OR  97124
ContactBret Andre
CorrespondentBret Andre
VASSEN CO., LTD. 474 NE 61ST PL. Hillsboro,  OR  97124
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-24
Decision Date2014-10-07
Summary:summary

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