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FDA 510(k) Application Details - K123023
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K123023
Device Name
System, Image Processing, Radiological
Applicant
SURGICAL THEATER, LLC
151 INNOVATION DR.
ELYRIA, OH 44141 US
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Contact
MORDECHAI AVISAR
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
09/28/2012
Decision Date
02/08/2013
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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