FDA 510(k) Application Details - K031396

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K031396
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant GE MEDICAL SYSTEMS
3000 N GRANDVIEW BLVD.
W-400
WAUKESHA, WI 53188 US
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Contact LARRY A KROGER
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 05/02/2003
Decision Date 05/13/2003
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 Y
Expedited Review



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