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 K885180
Device Name EXPANDABLE BILIARY STENT ENDOPROSTHESIS
Applicant
SCHNEIDER INTL., LTD.
2905 NORTHWEST BLVD.
MINNEAPOLIS,  MN  55441
Applicant Contact ALAN MARQUARDT
Correspondent
SCHNEIDER INTL., LTD.
2905 NORTHWEST BLVD.
MINNEAPOLIS,  MN  55441
Correspondent Contact ALAN MARQUARDT
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/14/1988
Decision Date 02/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-