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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K200741
Device Name Tablo Hemodialysis System
Outset Medical, Inc.
1830 Bering Drive
San Jose,  CA  95112
Applicant Contact Jennifer Mascioli-Tudor
Outset Medical, Inc.
1830 Bering Drive
San Jose,  CA  95112
Correspondent Contact Jennifer Mascioli-Tudor
Regulation Number876.5860
Classification Product Code
Subsequent Product Code
Date Received03/23/2020
Decision Date 03/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT02460263
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls