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 K983075
Device Name GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
Applicant Contact SANDRA SUNDELL
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
Correspondent Contact SANDRA SUNDELL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/02/1998
Decision Date 03/03/1999
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-