FDA 510(k) Application Details - K151560

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K151560
Device Name System,Planning,Radiation Therapy Treatment
Applicant Siris Medical
257 Castro Street, Ste 224
Mountain View, CA 94041 US
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Contact Colin M Carpenter
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 06/10/2015
Decision Date 09/11/2015
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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