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 K940396
Device Name WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)
Applicant
Boston Scientific Scimed, Inc.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact AMY PETERSON
Correspondent
Boston Scientific Scimed, Inc.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact AMY PETERSON
Regulation Number878.3610
Classification Product Code
ESW  
Date Received01/27/1994
Decision Date 10/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-