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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 K972443
Device Name MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS
Applicant
Menicon U.S.A., Inc.
333 W. Pontiac Way
Clovis,  CA  93612
Applicant Contact CRISTINA M SCHNIDER
Correspondent
Menicon U.S.A., Inc.
333 W. Pontiac Way
Clovis,  CA  93612
Correspondent Contact CRISTINA M SCHNIDER
Regulation Number886.5916
Classification Product Code
HQD  
Date Received06/30/1997
Decision Date 08/22/1997
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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