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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 K213639
Device Name Revaclear 500, Revaclear 400, Revaclear 300
Baxter Healthcare Corporation
32650 N Wilson Road
Round Lake,  IL  60073
Applicant Contact Jesse Seidman
Gambro Dasco Spa
via Modenese 66
Medolla,  IT 41037
Correspondent Contact Alberto Pancanti
Regulation Number876.5860
Classification Product Code
Date Received11/18/2021
Decision Date 01/24/2022
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