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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 K990643
Device Name PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
Applicant
Althin Medical AB an Affiliate of Baxter Intl
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact AMAURY SANCHEZ
Correspondent
Althin Medical AB an Affiliate of Baxter Intl
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact AMAURY SANCHEZ
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/26/1999
Decision Date 12/07/1999
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
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