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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 K171880
Device Name IRRAflow CNS System
Applicant
IRRAS Inc.
7452 Herschel Avenue
La Jolla,  CA  92037
Applicant Contact Dessi Lyakov
Correspondent
IRRAS Inc.
7452 Herschel Avenue
La Jolla,  CA  92037
Correspondent Contact Dessi Lyakov
Regulation Number882.5550
Classification Product Code
JXG  
Subsequent Product Code
GWM  
Date Received06/23/2017
Decision Date 07/13/2018
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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