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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 K853891
Device Name INDIRECT OPHTHALMOSCOPE
Applicant
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Applicant Contact MARIE PEDERSON
Correspondent
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Correspondent Contact MARIE PEDERSON
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received09/19/1985
Decision Date 10/04/1985
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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