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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer, Ophthalmic
510(k) Number K871611
Device Name ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540
Applicant
Allergan Humphrey
3081 Teagarden St.
San Leandro,  CA  94577
Applicant Contact DEAN A KNIGHT
Correspondent
Allergan Humphrey
3081 Teagarden St.
San Leandro,  CA  94577
Correspondent Contact DEAN A KNIGHT
Regulation Number886.1760
Classification Product Code
HKO  
Date Received04/10/1987
Decision Date 05/18/1987
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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