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 K082515
Device Name ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
Applicant
ASAHI KASEI MEDICAL CO., LTD.
1801 ROCKVILLE PIKE, SUITE 300
ROCKVILLE,  MD  20852
Applicant Contact DAVID L WEST
Correspondent
ASAHI KASEI MEDICAL CO., LTD.
1801 ROCKVILLE PIKE, SUITE 300
ROCKVILLE,  MD  20852
Correspondent Contact DAVID L WEST
Regulation Number876.5860
Classification Product Code
KDI  
Date Received09/02/2008
Decision Date 10/03/2008
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
Recalls CDRH Recalls
-
-