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, Preformed/Molded
510(k) Number K243126
Device Name TRACHEOBRONXANE™ DUMON®
Applicant
Novatech SA
Z.I. Athélia Iii -1058, Voie Antiope
La Ciotat Cedex,  FR 13705
Applicant Contact Montgomery Stuart K.
Correspondent
Novatech SA
Z.I. Athélia Iii -1058, Voie Antiope
La Ciotat Cedex,  FR 13705
Correspondent Contact Montgomery Stuart K.
Regulation Number878.3720
Classification Product Code
NWA  
Date Received09/30/2024
Decision Date 10/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-