FDA 510(k) Application Details - K071673

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K071673
Device Name Accelerator, Linear, Medical
Applicant ONC SOLUTIONS, INC.
84 SUGAR HILL LANE
MANCHESTER, NH 03109 US
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Contact JOHN SCHWAMB
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 06/19/2007
Decision Date 07/18/2007
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

FDA Source Information for K071673


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