FDA 510(k) Application Details - K101294

Device Classification Name System, Radiation Therapy, Charged-Particle, Medical

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510(K) Number K101294
Device Name System, Radiation Therapy, Charged-Particle, Medical
Applicant VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
3100 HANSEN WAY
PALO ALTO, CA 94304 US
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Contact VY TRAN
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Regulation Number 892.5050

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Classification Product Code LHN
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Date Received 05/10/2010
Decision Date 12/27/2010
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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