FDA 510(k) Application Details - K082331

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K082331
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN, PA 19355-1406 US
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Contact JUDITH CAMPBELL
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 08/14/2008
Decision Date 10/01/2008
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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