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 K013418
Device Name AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
Applicant
Asahi Medical Co., Ltd.
1801 Rockville Pike
Suite 300
Rockville,  MD  20852 -1632
Applicant Contact DAVID L WEST
Correspondent
Asahi Medical Co., Ltd.
1801 Rockville Pike
Suite 300
Rockville,  MD  20852 -1632
Correspondent Contact DAVID L WEST
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/15/2001
Decision Date 07/09/2002
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
Recalls CDRH Recalls
-
-