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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ventricular
510(k) Number K161731
Device Name Cleveland Multiport Ventricular Catheter Set
Applicant
Parker Hannifin Corp.
3007 Bunsen Ave.
Ventura,  CA  93003
Applicant Contact George Austria
Correspondent
Parker Hannifin Corp.
10411 Corporate Dr.
Suite 102
Pleasant Prarie,  WI  53158
Correspondent Contact Lisa Michels
Regulation Number882.4100
Classification Product Code
HCA  
Date Received06/23/2016
Decision Date 03/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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