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, high permeability with or without sealed dialysate system
510(k) Number K162488
Device Name Optiflux dialyzer
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
920 WINTER ST.
WALTHAM,  MA  02451
Applicant Contact DENISE OPPERMANN
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
920 WINTER ST.
WALTHAM,  MA  02451
Correspondent Contact DENISE OPPERMANN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received09/07/2016
Decision Date 04/06/2017
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
Recalls CDRH Recalls
-
-