FDA 510(k) Application Details - K031764

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K031764
Device Name Accelerator, Linear, Medical
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD, CA 94520 US
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Contact KEN NEHMER
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 06/09/2003
Decision Date 09/05/2003
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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