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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 K130930
Device Name OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
Applicant
Ningbo Lishunda Electronics Co., Ltd.
5 Carey St.
Pennington,  NJ  08534
Applicant Contact CHARLES SHEN
Correspondent
Ningbo Lishunda Electronics Co., Ltd.
5 Carey St.
Pennington,  NJ  08534
Correspondent Contact CHARLES SHEN
Regulation Number886.5928
Classification Product Code
LRX  
Date Received04/04/2013
Decision Date 02/12/2014
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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