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 K913950
Device Name DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY
Applicant
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014 -9308
Applicant Contact MARIAN D HARDING
Correspondent
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014 -9308
Correspondent Contact MARIAN D HARDING
Regulation Number876.5860
Classification Product Code
KDI  
Date Received09/04/1991
Decision Date 11/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-