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510(k) K103489

GE VEO RECONSTRUCTION OPTION by General Electric Co. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2011
Date Received
November 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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