FDA 510(k) Application Details - K121513

Device Classification Name System, X-Ray, Stationary

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510(K) Number K121513
Device Name System, X-Ray, Stationary
Applicant SIEMENS MEDICAL SOLUTION
51 VALLEY STREAM PKWY.
MALVERN, PA 19355 US
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Contact PATRICIA D JONES
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 05/21/2012
Decision Date 08/10/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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