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 K060557
Device Name SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060
Applicant
Idev Technologies, Inc.
1120 Nasa Pkwy., Suite 600
Houston,  TX  77058
Applicant Contact TIMOTHY R PLACEK
Correspondent
Idev Technologies, Inc.
1120 Nasa Pkwy., Suite 600
Houston,  TX  77058
Correspondent Contact TIMOTHY R PLACEK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/02/2006
Decision Date 08/15/2006
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
Predetermined Change
Control Plan Authorized		 No
-
-