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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, battery-powered
510(k) Number K950797
Device Name HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
Applicant
NEITZ INSTRUMENTS COMPANY, LTD.
36-13, WAKAMATSU-CHO,
SHINJUKU-KU
TOKYO,  JP 162-0056
Applicant Contact YASUO KAWANO
Correspondent
NEITZ INSTRUMENTS COMPANY, LTD.
36-13, WAKAMATSU-CHO,
SHINJUKU-KU
TOKYO,  JP 162-0056
Correspondent Contact YASUO KAWANO
Regulation Number886.1570
Classification Product Code
HLJ  
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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