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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 K190793
Device Name Tablo Hemodialysis System, Tablo Cartridge
Applicant
Outset Medical, Inc.
1830 Bering Drive
San Jose,  CA  95112
Applicant Contact Jennifer Mascioli-Tudor
Correspondent
Outset Medical, Inc.
1830 Bering Drive
San Jose,  CA  95112
Correspondent Contact Jennifer Mascioli-Tudor
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Codes
FIP   FJK  
Date Received03/28/2019
Decision Date 12/12/2019
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
Recalls CDRH Recalls
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