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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 K000233
Device Name MENICON SF-P
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 Received01/27/2000
Decision Date 05/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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