FDA 510(k) Application Details - K073290

Device Classification Name System, X-Ray, Angiographic

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510(K) Number K073290
Device Name System, X-Ray, Angiographic
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MS E-50
MALVERN, PA 19355 US
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Contact GARY JOHNSON
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Regulation Number 892.1600

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Classification Product Code IZI
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Date Received 11/21/2007
Decision Date 02/11/2008
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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