• 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 K980653
Device Name PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
Applicant
CORDIS CORP.
35 & 40 TECHNOLOGY DR.
WARREN,  NJ  07059
Applicant Contact CHARLES J RYAN
Correspondent
CORDIS CORP.
35 & 40 TECHNOLOGY DR.
WARREN,  NJ  07059
Correspondent Contact CHARLES J RYAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/11/1998
Decision Date 06/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-