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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 K120904
Device Name POLARIS DIAL-A-DATE CONTACT LENS CASE
Applicant
Reliance Design & Manufacture Corp.
611 W. Fifth St.
Thrid Floor
Austin,  TX  78701
Applicant Contact CAROLINE TONTINI
Correspondent
Reliance Design & Manufacture Corp.
611 W. Fifth St.
Thrid Floor
Austin,  TX  78701
Correspondent Contact CAROLINE TONTINI
Regulation Number886.5928
Classification Product Code
LRX  
Date Received03/26/2012
Decision Date 11/26/2012
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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