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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratoscope, ac-powered
510(k) Number K853723
Device Name ZEISS OPERATING KERATOMETER
Applicant
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Applicant Contact JANE PEDERSON
Correspondent
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Correspondent Contact JANE PEDERSON
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received09/05/1985
Decision Date 10/15/1985
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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