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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K162869
Device Name Contact Lens Case
Applicant
Ningbo Yinzhou Zonghai Artware Co., Ltd.
Honglianchi, Guangsheng Village, Jishigang Town
Yinzhou District
Ningbo City,  CN 315172
Applicant Contact Weng Changhai
Correspondent
Irc
7808 Rush Creek Dr.
Pasco,  WA  99301
Correspondent Contact Charles Mack
Regulation Number886.5928
Classification Product Code
LRX  
Date Received10/13/2016
Decision Date 12/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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