PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES

Case, Contact Lens

PROSBEN, INC.

The following data is part of a premarket notification filed by Prosben, Inc. with the FDA for Prosben Contact Lens Cases Model Ca66-02, Ca66-03wb, Ca66-04t Series.

Pre-market Notification Details

Device IDK122700
510k NumberK122700
Device Name:PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
ClassificationCase, Contact Lens
Applicant PROSBEN, INC. 11 F., NO. 58, SEC. 3 MINGCHAUN EAST ROAD Taipei,  TW 104
ContactJen Ke-min
CorrespondentJen Ke-min
PROSBEN, INC. 11 F., NO. 58, SEC. 3 MINGCHAUN EAST ROAD Taipei,  TW 104
Product CodeLRX  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-04
Decision Date2013-05-31
Summary:summary

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