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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 K212216
Device Name Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield,  IL  60015
Applicant Contact Fortunato (Tito) Aldape
Gambro Industries
7 Avenue Lionel Terray B.P 126
Meyzieu,  FR F-69883
Correspondent Contact Maud Humbert
Regulation Number876.5860
Classification Product Code
Date Received07/16/2021
Decision Date 04/01/2022
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
Recalls CDRH Recalls