FDA 510(k) Application Details - K060834

Device Classification Name System, Radiation Therapy, Charged-Particle, Medical

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510(K) Number K060834
Device Name System, Radiation Therapy, Charged-Particle, Medical
Applicant HITACHI, LTD.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
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Contact JONATHAN S KAHN
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Regulation Number 892.5050

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Classification Product Code LHN
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Date Received 03/27/2006
Decision Date 04/19/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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