FDA 510(k) Application Details - K123520

Device Classification Name Full Field Digital,System,X-Ray,Mammographic

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510(K) Number K123520
Device Name Full Field Digital,System,X-Ray,Mammographic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN, PA 19355-1406 US
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Contact PATRICIA D JONES
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Regulation Number 000.0000

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Classification Product Code MUE
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Date Received 11/15/2012
Decision Date 06/11/2013
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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