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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 K253412
Device Name Tablo Hemodialysis System (PN-0008000, PN-0006000U)
Applicant
Outset Medical, Inc.
3052 Orchard Ave.
San Jose,  CA  95134
Applicant Contact Dinamarie Stefani
Correspondent
Outset Medical, Inc.
3052 Orchard Ave.
San Jose,  CA  95134
Correspondent Contact Dinamarie Stefani
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Code
FIP  
Date Received09/30/2025
Decision Date 01/26/2026
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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