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 Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K033212
Device Name LIFESTENT SDS BILIARY ENDOPROSTHESIS
Applicant
ORBUS MEDICAL TECHNOLOGIES
5363 N.W. 35TH AVE.
FT. LAUDERDALE,  FL  33309 -6315
Applicant Contact JIM CLOSSICK
Correspondent
ORBUS MEDICAL TECHNOLOGIES
5363 N.W. 35TH AVE.
FT. LAUDERDALE,  FL  33309 -6315
Correspondent Contact JIM CLOSSICK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/03/2003
Decision Date 10/30/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-