FDA 510(k) Application Details - K090182

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K090182
Device Name System,Planning,Radiation Therapy Treatment
Applicant NUCLEMED S.A.
56B SHADOWBROOK DR.
HUDSON, NH 03051 US
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Contact RAYMOND KELLY
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 01/26/2009
Decision Date 05/04/2009
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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