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, Esophageal
510(k) Number K983297
Device Name MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE
Applicant
Medtronic Instent, Inc.
6271 Bury Dr.
Eden Prairie,  MN  55346
Applicant Contact NOEL MESSENGER
Correspondent
Medtronic Instent, Inc.
6271 Bury Dr.
Eden Prairie,  MN  55346
Correspondent Contact NOEL MESSENGER
Regulation Number878.3610
Classification Product Code
ESW  
Date Received09/21/1998
Decision Date 12/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-