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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K970019
Device Name MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
Applicant
Menicon U.S.A., Inc.
700 Thirteen St., NW
Suite 1200
Washington,  DC  20005
Applicant Contact S. WES SIEGNER, JR.
Correspondent
Menicon U.S.A., Inc.
700 Thirteen St., NW
Suite 1200
Washington,  DC  20005
Correspondent Contact S. WES SIEGNER, JR.
Regulation Number886.5925
Classification Product Code
LPL  
Date Received01/02/1997
Decision Date 03/25/1997
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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