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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 K083387
Device Name MODIFICATION TO KOWA NONMYD ALPHA-DIII
Applicant
Kowa Co. , Ltd.
4-14, Nihonbashi-Honcho 3-Chome
Chuo-Ku, Tokyo,  JP 103-8433
Applicant Contact AKIHIRO FUJITA
Correspondent
Kowa Co. , Ltd.
4-14, Nihonbashi-Honcho 3-Chome
Chuo-Ku, Tokyo,  JP 103-8433
Correspondent Contact Hiroyuki Koide
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
NFW  
Date Received11/17/2008
Decision Date 01/16/2009
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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