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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 K123605
Device Name SMARTFLOW CATHETER
Applicant
MRI INTERVENTIONS, INC.
5 MUSICK
IRVINE,  CA  92618
Applicant Contact EDWARD F WADDELL
Correspondent
MRI INTERVENTIONS, INC.
5 MUSICK
IRVINE,  CA  92618
Correspondent Contact EDWARD F WADDELL
Regulation Number882.4100
Classification Product Code
HCA  
Date Received11/21/2012
Decision Date 08/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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