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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 K120969
Device Name AC LENS BRANDED CONTACT LENS CASE
Applicant
Arlington Contact Lens Services,Inc.
1468 Harwell Ave.,
Crofton,  MD  21114
Applicant Contact Christian Smith
Correspondent
Arlington Contact Lens Services,Inc.
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact Christian Smith
Regulation Number886.5928
Classification Product Code
LRX  
Date Received03/30/2012
Decision Date 07/11/2012
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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