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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 K171539
Device Name Contact Lens Case
Applicant
E-Link Plastic & Metal Industrial Co.,Ltd
#69-40, Hsing Shuh Rd.
Hsing Chung Zone
New Taipei,  CN 24262
Applicant Contact Marvis Lee
Correspondent
Shenzhen Hlongmed Biotech Company
1002, 10th Floor, Zhongxing Administrative Bldg.,
Zhongxing Industrial Zone, Chuangye Rd., Nanshan
Shenzhen,  CN 518054
Correspondent Contact Long Yang
Regulation Number886.5928
Classification Product Code
LRX  
Date Received05/26/2017
Decision Date 07/14/2017
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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