FDA 510(k) Application Details - K052202

Device Classification Name

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510(K) Number K052202
Device Name AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PARKWAY, E-50
MALVERN, PA 19355 US
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Contact GARY JOHNSON
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Regulation Number

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Classification Product Code OWB
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Date Received 08/12/2005
Decision Date 03/07/2006
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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