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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 K881219
Device Name AUTOMATIC PERIMETER, AP-340
Applicant
KOWA OPTIMED, INC.
20001 SOUTH VERMONT AVE.
TORRANCE,  CA  90502
Applicant Contact MIKE YAMASHITA
Correspondent
KOWA OPTIMED, INC.
20001 SOUTH VERMONT AVE.
TORRANCE,  CA  90502
Correspondent Contact MIKE YAMASHITA
Regulation Number886.1605
Classification Product Code
HPT  
Date Received03/22/1988
Decision Date 05/03/1988
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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