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 Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K012242
Device Name FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
Applicant
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420
Applicant Contact ARTHUR EILINSFELD
Correspondent
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420
Correspondent Contact ARTHUR EILINSFELD
Regulation Number876.5820
Classification Product Code
FJK  
Date Received07/17/2001
Decision Date 08/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-