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510(k) K152361

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System by Liebel-Flarsheim Company, LLC — Product Code IZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2016
Date Received
August 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

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