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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, ac-powered
510(k) Number K942713
Device Name NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H
Applicant
NEITZ INSTRUMENTS COMPANY, LTD.
1050 CONNECTICUT AVE., N.W.
WASHINGTON,  DC 
Applicant Contact TRACY BERNS
Correspondent
NEITZ INSTRUMENTS COMPANY, LTD.
1050 CONNECTICUT AVE., N.W.
WASHINGTON,  DC 
Correspondent Contact TRACY BERNS
Regulation Number886.1570
Classification Product Code
HLI  
Date Received06/09/1994
Decision Date 08/05/1994
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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