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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 K031831
Device Name TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
Applicant
TOPCON MEDICAL SYSTEMS, INC.
37 WEST CENTURY RD.
PARAMUS,  NJ  07652
Applicant Contact DONALD H WINFIELD
Correspondent
TOPCON MEDICAL SYSTEMS, INC.
37 WEST CENTURY RD.
PARAMUS,  NJ  07652
Correspondent Contact DONALD H WINFIELD
Regulation Number886.1760
Classification Product Code
HKO  
Subsequent Product Codes
HKN   HOX  
Date Received06/13/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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