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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 K222471
Device Name IRRAflow Active Fluid Exchange System (AFES)
Applicant
Irras USA
11975 El Camino Real
Suite 304
San Diego,  CA  92130
Applicant Contact Jeanne S Warner
Correspondent
Irras USA
11975 El Camino Real
Suite 304
San Diego,  CA  92130
Correspondent Contact Jeanne S Warner
Regulation Number882.5550
Classification Product Code
JXG  
Subsequent Product Code
GWM  
Date Received08/16/2022
Decision Date 12/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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