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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 K150880
Device Name Tablo Console with Wireless Capability
Outset Medical
1830 Bering Drive
San Jose,  CA  95112
Applicant Contact Nancy Gallo
Outset Medical
1830 Bering Drive
San Jose,  CA  95112
Correspondent Contact Nancy Gallo
Regulation Number876.5860
Classification Product Code
Subsequent Product Code
Date Received04/01/2015
Decision Date 05/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No