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 Prosthesis, Tracheal, Expandable
510(k) Number K013648
Device Name VIABAHN ENDOPROSTHESIS
Applicant
W. L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21922
Applicant Contact TIMOTHY J RYNN
Correspondent
W. L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21922
Correspondent Contact TIMOTHY J RYNN
Regulation Number878.3720
Classification Product Code
JCT  
Date Received11/05/2001
Decision Date 01/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-