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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 K962006
Device Name MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Applicant
Menicon Co, Ltd.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Applicant Contact A. WES SIEGNER,, JR.
Correspondent
Menicon Co, Ltd.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact A. WES SIEGNER,, JR.
Regulation Number886.5916
Classification Product Code
HQD  
Date Received05/22/1996
Decision Date 10/09/1996
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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