Contact Lens Case

Case, Contact Lens

Ningbo Yinzhou Zonghai Artware Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Yinzhou Zonghai Artware Co., Ltd. with the FDA for Contact Lens Case.

Pre-market Notification Details

Device IDK162869
510k NumberK162869
Device Name:Contact Lens Case
ClassificationCase, Contact Lens
Applicant Ningbo Yinzhou Zonghai Artware Co., Ltd. Honglianchi, Guangsheng Village, Jishigang Town Yinzhou District Ningbo City,  CN 315172
ContactWeng Changhai
CorrespondentCharles Mack
IRC 7808 Rush Creek Drive Pasco,  WA  99301
Product CodeLRX  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-13
Decision Date2016-12-09
Summary:summary

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