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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 K945620
Device Name ALTRA FLUX(TM) 140 HEMODIALYZER
Applicant
Althin Medical AB an Affiliate of Baxter Intl
14620 NW 60th Ave.
Miami Lakes,  FL  33014 -9308
Applicant Contact MARY LANE
Correspondent
Althin Medical AB an Affiliate of Baxter Intl
14620 NW 60th Ave.
Miami Lakes,  FL  33014 -9308
Correspondent Contact MARY LANE
Regulation Number876.5860
Classification Product Code
KDI  
Date Received11/15/1994
Decision Date 05/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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