FDA 510(k) Application Details - K091403

Device Classification Name Block, Beam-Shaping, Radiation Therapy

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510(K) Number K091403
Device Name Block, Beam-Shaping, Radiation Therapy
Applicant ONCOLOGY TECH, LLC
5608 BUSINESS PARK
SAN ANTONIO, TX 78218 US
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Contact SEAN COMER
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Regulation Number 892.5710

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Classification Product Code IXI
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Date Received 05/12/2009
Decision Date 07/29/2009
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 N
Expedited Review



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