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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 K160444
Device Name FB-U Hemodialyzer
Applicant
Nipro Medical Corporation
3150 NW 107th Ave.
Doral,  FL  33172
Applicant Contact JESSICA OSWALD-MCLEOD
Correspondent
Nipro Medical Corporation
3150 NW 107th Ave.
Doral,  FL  33172
Correspondent Contact JESSICA OSWALD-MCLEOD
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/17/2016
Decision Date 02/08/2017
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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