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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 K112832
Device Name EYE CARE CURE CONTACT LENS CASE
Applicant
Eye Care and Cure
4646 S Overland Dr.
Tucson,  AZ  85714
Applicant Contact LINDY V DALEN
Correspondent
Eye Care and Cure
4646 S Overland Dr.
Tucson,  AZ  85714
Correspondent Contact LINDY V DALEN
Regulation Number886.5928
Classification Product Code
LRX  
Date Received09/29/2011
Decision Date 12/05/2011
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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