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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
Applicant
Baxter Healthcare Corporation
32650 N Wilson Road
Round Lake,  IL  60073
Applicant Contact Jesse Seidman
Correspondent
Gambro Dasco Spa
via Modenese 66
Medolla,  IT 41037
Correspondent Contact Alberto Pancanti
Regulation Number876.5860
Classification Product Code
KDI  
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
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