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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
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