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FDA 510(k) Application Details - K141480
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K141480
Device Name
System, Image Processing, Radiological
Applicant
CIRCLE CARDIOVASCULAR IMAGING INC
Suite 250, 815 8th Avenue SW
Calgary T2P 3P2 CA
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Contact
SHIRANTHA SAMARAPPULI
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
06/04/2014
Decision Date
08/22/2014
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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