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FDA 510(k) Application Details - K173689
Device Classification Name
System, Image Management, Ophthalmic
More FDA Info for this Device
510(K) Number
K173689
Device Name
System, Image Management, Ophthalmic
Applicant
Canon Inc. -Medical Equipment Group
9-1, Imaikami-cho,
Nakahara-ku, Kawasaki 211-8501 JP
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Contact
Shinji Mori
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
NFJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2017
Decision Date
02/23/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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