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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 K171671
Device Name Prismaflex System 8.10
Applicant
Baxter Healthcare Corporation
32650 North Wilson Road
Round Lake,  IL  60073
Applicant Contact Rick Lukacovic
Correspondent
Baxter Healthcare Corporation
32650 North Wilson Road
Round Lake,  IL  60073
Correspondent Contact Rick Lukacovic
Regulation Number876.5860
Classification Product Code
KDI  
Date Received06/06/2017
Decision Date 02/23/2018
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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