FDA 510(k) Application Details - K982696

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K982696
Device Name System,Planning,Radiation Therapy Treatment
Applicant BURDETTE MEDICAL SYSTEMS, INC.
206 N. RANDOLPH ST.
SUITE 301
CHAMPAIGN, IL 61820 US
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Contact EVERETTE C BURDETTE
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 08/03/1998
Decision Date 04/01/1999
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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