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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 K843597
Device Name NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
Applicant
NIDEK, INC.
P.O. BOX 50488
PALO ALTO,  CA  94303 -
Applicant Contact THERESA M NEWTON
Correspondent
NIDEK, INC.
P.O. BOX 50488
PALO ALTO,  CA  94303 -
Correspondent Contact THERESA M NEWTON
Regulation Number886.1570
Classification Product Code
HLI  
Date Received09/12/1984
Decision Date 02/15/1985
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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