FDA 510(k) Application Details - K111710

Device Classification Name Tonometer, Ac-Powered

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510(K) Number K111710
Device Name Tonometer, Ac-Powered
Applicant CANON, INC.-MEDICAL EQUIPMENT GROUP
C/O COSMOS CORPORATION
3F 2-17-6 AKEBONO-CHO
TACHIKAWA-SHI, TOKYO 190-0012 JP
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Contact KOJI KUBO
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Regulation Number 886.1930

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Classification Product Code HKX
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Date Received 06/20/2011
Decision Date 09/20/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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