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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name perimeter, automatic, ac-powered
510(k) Number K954167
Device Name HUMPHREY FIELD ANALYZER (HFA II)
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 Number886.1605
Classification Product Code
HPT  
Date Received09/05/1995
Decision Date 11/24/1995
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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