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 Filter, Blood, Dialysis
510(k) Number K820575
Device Name J.E.T. DIALYSIS SYSTEM
Applicant
Computer Dialysis Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Computer Dialysis Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5820
Classification Product Code
FKJ  
Date Received03/03/1982
Decision Date 05/20/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-