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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Contrast Medium, Automatic
510(k) Number K152361
Device Name OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
Applicant
Liebel-Flarsheim Company, LLC
2111 E. Galbraith Rd.
Cincinnati,  OH  45237
Applicant Contact Craig Buehler
Correspondent
Liebel-Flarsheim Company, LLC
2111 E. Galbraith Rd.
Cincinnati,  OH  45237
Correspondent Contact Craig Buehler
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received08/20/2015
Decision Date 01/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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