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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Contact Lens Care, Rigid Gas Permeable
510(k) Number K130805
Device Name MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
Applicant
Menicon Co, Ltd.
187 Ballardvale St., Suite 180
Wilmington,  MA  01887
Applicant Contact Ellen M Beucler
Correspondent
Menicon Co, Ltd.
187 Ballardvale St., Suite 180
Wilmington,  MA  01887
Correspondent Contact Ellen M Beucler
Regulation Number886.5918
Classification Product Code
MRC  
Date Received03/25/2013
Decision Date 07/03/2013
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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