Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name dialyzer, capillary, hollow fiber
510(k) Number K122952
Device Name NIPRO PUREFLUX-L HEMODIALYZER
Applicant
NIPRO MEDICAL CORPORATION
6695 RIVER CREST PT
SUWANEE,  GA  30024
Applicant Contact CAROLYN GEAORGE
Correspondent
NIPRO MEDICAL CORPORATION
6695 RIVER CREST PT
SUWANEE,  GA  30024
Correspondent Contact CAROLYN GEAORGE
Regulation Number876.5820
Classification Product Code
FJI  
Date Received09/25/2012
Decision Date 12/04/2013
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
-
-