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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tonometer, ac-powered
510(k) Number K111710
Device Name FULL AUTO TONOMETER MODEL TX-20
Applicant
CANON, INC.-MEDICAL EQUIPMENT GROUP
C/O COSMOS CORPORATION
3F 2-17-6 AKEBONO-CHO
TACHIKAWA-SHI, TOKYO,  JP 190-0012
Applicant Contact KOJI KUBO
Correspondent
CANON, INC.-MEDICAL EQUIPMENT GROUP
C/O COSMOS CORPORATION
3F 2-17-6 AKEBONO-CHO
TACHIKAWA-SHI, TOKYO,  JP 190-0012
Correspondent Contact KOJI KUBO
Regulation Number886.1930
Classification Product Code
HKX  
Date Received06/20/2011
Decision Date 09/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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