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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 K954780
Device Name KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
Applicant
KOWA OPTIMED, INC.
700 THIRTEENTH STREET, N.W.
SUITE 1200
WASHINGTON,  DC  20005
Applicant Contact SAMIA N RODRIGUEZ
Correspondent
KOWA OPTIMED, INC.
700 THIRTEENTH STREET, N.W.
SUITE 1200
WASHINGTON,  DC  20005
Correspondent Contact SAMIA N RODRIGUEZ
Regulation Number886.1120
Classification Product Code
HKI  
Date Received10/17/1995
Decision Date 12/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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