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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, peritoneal, automatic delivery
510(k) Number K201867
Device Name Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
Applicant
Baxter Healthcare Corporation
25212 W. Illinois Route 120
Round Lake,  IL  60073
Applicant Contact Brad Roynon
Correspondent
Baxter Healthcare Corporation
25212 W. Illinois Route 120
Round Lake,  IL  60073
Correspondent Contact Brad Roynon
Regulation Number876.5630
Classification Product Code
FKX  
Date Received07/07/2020
Decision Date 11/19/2020
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
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