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FDA 510(k) Application Details - K153612
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K153612
Device Name
System, Image Processing, Radiological
Applicant
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
10000 CEDAR AVENUE
CLEVELAND, OH 44106 US
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Contact
Keith Grafmeyer
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
12/17/2015
Decision Date
03/15/2016
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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