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 K914881
Device Name WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
Applicant
Wiltek Medical, Inc.
P.O.Box 11946
Winston-Salem,  NC  27116
Applicant Contact JON S WILSON
Correspondent
Wiltek Medical, Inc.
P.O.Box 11946
Winston-Salem,  NC  27116
Correspondent Contact JON S WILSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/30/1991
Decision Date 01/07/1992
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
-
-