FDA 510(k) Application Details - K984167

Device Classification Name System, Nuclear Magnetic Resonance Spectroscopic

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510(K) Number K984167
Device Name System, Nuclear Magnetic Resonance Spectroscopic
Applicant GE MEDICAL SYSTEMS
3200 N. GRANDVIEW BLVD.
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 LNI
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Date Received 11/20/1998
Decision Date 01/12/1999
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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