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FDA 510(k) Application Details - K180410
Device Classification Name
System, Hemodialysis, Access Recirculation Monitoring
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510(K) Number
K180410
Device Name
System, Hemodialysis, Access Recirculation Monitoring
Applicant
Dosis, Inc.
4388 El Camino Real, Unit 330
Los Altos, CA 94022 US
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Contact
Divya Chhabra
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Regulation Number
876.5820
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Classification Product Code
MQS
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More FDA Info for this Product Code
Date Received
02/14/2018
Decision Date
01/16/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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