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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name perimeter, automatic, ac-powered
510(k) Number K961090
Device Name AUTOMATIC VISUAL FIELD PLOTTER AP-125
Applicant
KOWA OPTIMED, INC.
700 THIRTEENTH STREET, N.W.
SUITE 1200
WASHINGTON,  DC  20005
Applicant Contact HIROSHI OKADA
Correspondent
KOWA OPTIMED, INC.
700 THIRTEENTH STREET, N.W.
SUITE 1200
WASHINGTON,  DC  20005
Correspondent Contact HIROSHI OKADA
Regulation Number886.1605
Classification Product Code
HPT  
Date Received03/19/1996
Decision Date 06/17/1996
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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