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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 K080681
Device Name KOWA GENESIS-D
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 Received03/10/2008
Decision Date 04/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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