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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 K972440
Device Name CATARACTSCREENER CT - S
Applicant
Neitz Instruments Company, Ltd.
36-13, Wakamatsu-Cho,
Shinjuku-Ku
Tokyo,  JP 162-0056
Applicant Contact MASAO SUGASAWA
Correspondent
Neitz Instruments Company, Ltd.
36-13, Wakamatsu-Cho,
Shinjuku-Ku
Tokyo,  JP 162-0056
Correspondent Contact MASAO SUGASAWA
Regulation Number886.1120
Classification Product Code
HKI  
Date Received06/30/1997
Decision Date 09/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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