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FDA 510(k) Application Details - K200887
Device Classification Name
More FDA Info for this Device
510(K) Number
K200887
Device Name
AS-10
Applicant
Canon, Inc.
9-1 Imaikami-Cho, Nakahara-Ku
Kawasaki 211-8501 JP
Other 510(k) Applications for this Company
Contact
Akira Hirai
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/02/2020
Decision Date
04/15/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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