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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 K133299
Device Name ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
Applicant
FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER
920 WINTER ST.
WALTHAM,  MA  02451
Applicant Contact DENISE M OPPERMANN
Correspondent
FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER
920 WINTER ST.
WALTHAM,  MA  02451
Correspondent Contact DENISE M OPPERMANN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/25/2013
Decision Date 07/07/2014
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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