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FDA 510(k) Application Details - K140337
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K140337
Device Name
System, Image Processing, Radiological
Applicant
SYNAPTIVE MEDICAL INC.
101 COLLEGE STREET
SUITE 200
TORONTO, ONTARIO M5G 1L7 CA
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Contact
CAMERON PIRON
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/10/2014
Decision Date
06/02/2014
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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