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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 K171163
Device Name Contact Lens Case Round Glasses
Applicant
Fiftytwoways, Ltd.
Unit 4, 7th Floor, Flat B, Grand Ind. Bldg, 159-165
Wo Yi Hop Rd.
Kwai Chung,  HK
Applicant Contact Jos Reinders
Correspondent
Fiftytwoways, Ltd.
Unit 4, 7th Floor, Flat B, Grand Ind. Bldg, 159-165
Wo Yi Hop Rd.
Kwai Chung,  HK
Correspondent Contact Jos Reinders
Regulation Number886.5928
Classification Product Code
LRX  
Date Received04/20/2017
Decision Date 06/27/2017
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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