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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 K193482
Device Name PrisMax System Version 3
Applicant
Baxter Healthcare Corporation
7601 Northland Dr.
Brooklyn Park,  MN  55428
Applicant Contact Christopher Scavotto
Correspondent
Baxter Healthcare Corporation
7601 Northland Dr.
Brooklyn Park,  MN  55428
Correspondent Contact Christopher Scavotto
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/17/2019
Decision Date 03/13/2020
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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