FDA 510(k) Application Details - K142049

Device Classification Name System, X-Ray, Stationary

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510(K) Number K142049
Device Name System, X-Ray, Stationary
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PARKWAY
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 07/28/2014
Decision Date 12/18/2014
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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