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FDA 510(k) Application Details - K172327
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K172327
Device Name
System, Image Processing, Radiological
Applicant
Ortho Kinematics, Inc.
110 Wild Basin Road, Suite 250
Austin, TX 78704 US
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Contact
Adam Deitz
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
08/01/2017
Decision Date
08/25/2017
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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