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 Hemodialyzer, Re-Use, High Flux
510(k) Number K970679
Device Name ALTRA FLUX 200 HEMODIALYZER
Applicant
Althin Medical AB an Affiliate of Baxter Intl
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact AMAURY SANCHEZ
Correspondent
Althin Medical AB an Affiliate of Baxter Intl
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact AMAURY SANCHEZ
Regulation Number876.5860
Classification Product Code
MSF  
Date Received02/24/1997
Decision Date 07/23/1998
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
-
-