FDA 510(k) Application Details - K061152

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

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510(K) Number K061152
Device Name System, Radiation Therapy, Charged-Particle, Medical
Applicant ONCOLOGY DATA SYSTEMS, INC.
1601 SW 89TH STREET
BUILDING E-100
OKLAHOMA CITY, OK 73159 US
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Contact GREG MILLER
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Regulation Number 892.5050

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Classification Product Code LHN
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Date Received 04/26/2006
Decision Date 05/10/2006
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 Y
Expedited Review



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