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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
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