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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 K122343
Device Name PUREFLUX-H HEMODIALYZER
Applicant
NIPRO MEDICAL CORPORATION
6695 RIVER CREST PT
SUWANEE,  GA  30024
Applicant Contact CAROLYN GEORGE
Correspondent
NIPRO MEDICAL CORPORATION
6695 RIVER CREST PT
SUWANEE,  GA  30024
Correspondent Contact CAROLYN GEORGE
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/03/2012
Decision Date 05/07/2013
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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