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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K081443
Device Name MENICON Z RIGID GAS PERMEABLE CONTACT LENS
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 Number886.5916
Classification Product Code
HQD  
Date Received05/22/2008
Decision Date 09/23/2008
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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