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 K113551
Device Name ESOPHAGEAL TTS STENT
Applicant
TAEWOONG MEDICAL CO., LTD
400 N. WASHINGTON ST
SUITE 100
ALEXANDRIA,  VA  22314
Applicant Contact STEPHEN RHODES
Correspondent
TAEWOONG MEDICAL CO., LTD
400 N. WASHINGTON ST
SUITE 100
ALEXANDRIA,  VA  22314
Correspondent Contact STEPHEN RHODES
Regulation Number878.3610
Classification Product Code
ESW  
Date Received12/01/2011
Decision Date 02/14/2012
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
Recalls CDRH Recalls
-
-