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FDA 510(k) Application Details - K143718
Device Classification Name
More FDA Info for this Device
510(K) Number
K143718
Device Name
Mammography Color Display DP-M3010
Applicant
CANON INC.
22-5, Tamura 9-chome
Hiratsuka-shi 254-0013 JP
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Contact
MASAKI TAMURA
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PGY
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More FDA Info for this Product Code
Date Received
12/29/2014
Decision Date
01/22/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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