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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 K160005
Device Name Contact Lens Case (multiple brand name)
Applicant
Danyang Chanxin Glasses Cases Factory
Huadian Chuangye Park, Dangui Rd., Developing Zone
Danyang City,  CN 212300
Applicant Contact LEMON CHEN
Correspondent
Osmunda Medical Device Service Group
Level 7, Jin Gui Business Center, 982 Cunyun Rd.
Baiyun District
Guangzhou,  CN 510420
Correspondent Contact MIKE GU
Regulation Number886.5928
Classification Product Code
LRX  
Date Received01/04/2016
Decision Date 06/07/2016
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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