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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name retinoscope, ac-powered
510(k) Number K950789
Device Name STREAK RETINOSCOPE RX-1
Original Applicant
NEITZ INSTRUMENTS COMPANY, LTD.
36-13, wakamatsu-cho,
shinjuku-ku
tokyo,  JP 162-0056
Original Contact yasuo kawano
Regulation Number886.1780
Classification Product Code
HKL  
Date Received02/21/1995
Decision Date 03/28/1995
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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