FDA 510(k) Application Details - K102583

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K102583
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 VINCENT RUMINER
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 09/08/2010
Decision Date 11/02/2010
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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