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FDA 510(k) Application Details - K130743
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K130743
Device Name
System, Image Processing, Radiological
Applicant
ORTHO KINEMATICS, INC.
555 13TH STREET NW
WASHINGTON, DC 20005-3096 US
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Contact
JOHN J SMITH
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
03/19/2013
Decision Date
08/06/2013
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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