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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K101628
Device Name KOWA NONMYD WX
Applicant
Kowa Co. , Ltd.
4-14, Nihonbashi-Honcho 3-Chome
Chuo-Ku, Tokyo,  JP 103-8433
Applicant Contact SATOHIKO TAKANASHI
Correspondent
Kowa Co. , Ltd.
4-14, Nihonbashi-Honcho 3-Chome
Chuo-Ku, Tokyo,  JP 103-8433
Correspondent Contact SATOHIKO TAKANASHI
Regulation Number886.1120
Classification Product Code
HKI  
Date Received06/10/2010
Decision Date 01/26/2011
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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