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 System, Dialysate Delivery, Semi-Automatic, Peritoneal
510(k) Number K970989
Device Name CYBERREN
Applicant
Cybernius Medical , Ltd.
Suite 200, Grandin Park Plz.
22 Sir Winston Churchill Ave.
St. Albert, Alberta,  CA T8N 1B4
Applicant Contact ULRICH SIMONSMEIER
Correspondent
Cybernius Medical , Ltd.
Suite 200, Grandin Park Plz.
22 Sir Winston Churchill Ave.
St. Albert, Alberta,  CA T8N 1B4
Correspondent Contact ULRICH SIMONSMEIER
Regulation Number876.5630
Classification Product Code
KPF  
Subsequent Product Code
FKP  
Date Received03/18/1997
Decision Date 07/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-