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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 K821940
Device Name THE HUMPHREY FIELD ANALYZER MODEL 610
Applicant
Zeiss Humphrey System
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Zeiss Humphrey System
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.1605
Classification Product Code
HPT  
Date Received06/29/1982
Decision Date 07/28/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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