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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.
269A BALLARDVALE ST.
WILMINGTON,  MA  01887
Applicant Contact BEVERLEY D VENUTI
Correspondent
MENICON CO. LTD.
269A 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
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