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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemodialysis, Access Recirculation Monitoring
510(k) Number K180410
Device Name Dosis SAM
Applicant
Dosis, Inc.
4388 El Camino Real, Unit 330
Los Altos,  CA  94022
Applicant Contact Divya Chhabra
Correspondent
Smith Assoicates
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number876.5820
Classification Product Code
MQS  
Date Received02/14/2018
Decision Date 01/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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