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FDA 510(k) Application Details - K113408
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K113408
Device Name
System, Tomography, Computed, Emission
Applicant
GE MEDICAL SYSTEMS, LLC
3000 N GRANDVIEW BLVD.
WAUKESHA, WI 53188 US
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Contact
DAVID DUERSTELER
Other 510(k) Applications for this Contact
Regulation Number
892.1200
More FDA Info for this Regulation Number
Classification Product Code
KPS
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More FDA Info for this Product Code
Date Received
11/18/2011
Decision Date
02/24/2012
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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