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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K852638
Device Name HUMPHREY IMAGE ANALYZER MODEL 110
Applicant
ZEISS HUMPHREY SYSTEM
2992 ALVARADO ST.
P.O. BOX 5400
SAN LEANDRO,  CA  94577
Applicant Contact DEAN A KNIGHT
Correspondent
ZEISS HUMPHREY SYSTEM
2992 ALVARADO ST.
P.O. BOX 5400
SAN LEANDRO,  CA  94577
Correspondent Contact DEAN A KNIGHT
Regulation Number886.1120
Classification Product Code
HKI  
Date Received06/20/1985
Decision Date 08/12/1985
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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