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510(k) K151048

CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set by Bracco Injeneering — Product Code IZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2016
Date Received
April 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Contrast Medium, Automatic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Bracco Injeneering

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