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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 K122273
Device Name MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
Applicant
MENICON CO. LTD.
187 BALLARDVALE STREET
SUITE 180
WILMINGTON,  MA  01887
Applicant Contact Ellen M Beucler
Correspondent
MENICON CO. LTD.
187 BALLARDVALE STREET
SUITE 180
WILMINGTON,  MA  01887
Correspondent Contact Ellen M Beucler
Regulation Number886.5918
Classification Product Code
MRC  
Date Received07/30/2012
Decision Date 01/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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