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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 K961171
Device Name HUMPHREY OCT SCANNER
Applicant
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Applicant Contact KENNETH M NICOLL
Correspondent
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Correspondent Contact KENNETH M NICOLL
Regulation Number886.1570
Classification Product Code
HLI  
Subsequent Product Code
IYO  
Date Received03/25/1996
Decision Date 06/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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