FDA 510(k) Application Details - K132944

Device Classification Name System, Simulation, Radiation Therapy

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510(K) Number K132944
Device Name System, Simulation, Radiation Therapy
Applicant GE HUNGARY KFT
DBA GE HEALTHCARE
3000 N GRANDVIEW
WAUKESHA, WI 53188 US
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Contact STEPHEN SLAVENS
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Regulation Number 892.5840

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Classification Product Code KPQ
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Date Received 09/19/2013
Decision Date 03/14/2014
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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