FDA 510(k) Application Details - K991237

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K991237
Device Name System,Planning,Radiation Therapy Treatment
Applicant RADIONICS, INC.
22 TERRY AVE.
BURLINGTON, MA 01803-2516 US
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Contact NANCY MACDONALD
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 04/12/1999
Decision Date 08/30/1999
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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