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 K921134
Device Name FRESENIUS POLYSULFONE DIALYZERS
Applicant
Fresenius USA, Inc.
2637 Shadelands Dr.
Walnut Creek,  CA  94598
Applicant Contact TOM FOLDEN
Correspondent
Fresenius USA, Inc.
2637 Shadelands Dr.
Walnut Creek,  CA  94598
Correspondent Contact TOM FOLDEN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/10/1992
Decision Date 12/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-