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FDA 510(k) Application Details - K073153
Device Classification Name
System, X-Ray, Tomography, Computed
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510(K) Number
K073153
Device Name
System, X-Ray, Tomography, Computed
Applicant
GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE BP 34
BUC CEDEX 78533 FR
Other 510(k) Applications for this Company
Regulation Number
892.1750
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Classification Product Code
JAK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/08/2007
Decision Date
02/26/2008
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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