FDA 510(k) Application Details - K091602

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K091602
Device Name Accelerator, Linear, Medical
Applicant ONCOLOGY DATA SYSTEMS, INC.
1601 SW 89TH STREET
BUILDING E-100
OKLAHOMA CITY, OK 73159 US
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Contact VINCE RUMINER
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 06/03/2009
Decision Date 06/18/2009
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

FDA Source Information for K091602


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