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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shunt, central nervous system and components
510(k) Number K192289
Device Name IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
Applicant
IRRAS USA, Ltd.
11975 El Camino Real, Suite 304
San Diego,  CA  92130
Applicant Contact Vinny Podichetty
Correspondent
IRRAS USA, Ltd.
11975 El Camino Real, 3rd Floor
San Diego,  CA  92130
Correspondent Contact Niloufa Insanally
Regulation Number882.5550
Classification Product Code
JXG  
Subsequent Product Code
GWM  
Date Received08/23/2019
Decision Date 11/15/2019
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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