FDA 510(k) Application Details - K954874

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K954874
Device Name System, Tomography, Computed, Emission
Applicant GE MEDICAL SYSTEMS
3000 N. GRANDVIEW BLVD.
WAUKESHA, WI 53188 US
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Contact LARRY A KROGER
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 10/24/1995
Decision Date 02/26/1996
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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