FDA 510(k) Application Details - K022961

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K022961
Device Name System,Planning,Radiation Therapy Treatment
Applicant MATH RESOLUTIONS, LLC.
5975 GALES LN.
COLUMBIA, MD 21045 US
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Contact WENDEL DEAN RENNER
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 09/06/2002
Decision Date 01/31/2003
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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