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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 K020930
Device Name MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
Applicant
Menicon Co, Ltd.
269 A Ballardvale St.
Wilmington,  MA  01887
Applicant Contact BEVERLEY D VENUTI
Correspondent
Menicon Co, Ltd.
269 A Ballardvale St.
Wilmington,  MA  01887
Correspondent Contact BEVERLEY D VENUTI
Regulation Number886.5918
Classification Product Code
MRC  
Date Received03/22/2002
Decision Date 05/02/2002
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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