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 K090682
Device Name EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00
Applicant
Edwards Lifesciences Services GmbH
Biopark, Broadwater Rd.
Welwyn Garden City,  GB AL7 3AX
Applicant Contact NEIL R ARMSTRONG
Correspondent
Edwards Lifesciences Services GmbH
Biopark, Broadwater Rd.
Welwyn Garden City,  GB AL7 3AX
Correspondent Contact NEIL R ARMSTRONG
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/16/2009
Decision Date 11/19/2009
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
-
-