FDA 510(k) Application Details - K102155

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K102155
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant GE MEDICAL SYSTEMS, LLC
3200 N. GRANDVIEW BLVD.
WAUKESHA, WI 53188 US
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Contact TRACEY FOX
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 07/30/2010
Decision Date 08/31/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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