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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 K050271
Device Name KOWA GENESIS-D HAND-HELD RETINAL CAMERA
Applicant
Kowa Co. , Ltd.
4-14, Nihonbashi-Honcho 3-Chome
Chuo-Ku, Tokyo,  JP 103-8433
Applicant Contact SATOHIKO TAKANISHI
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number886.1120
Classification Product Code
HKI  
Date Received02/04/2005
Decision Date 11/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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