• 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 tube tracheostomy and tube cuff
510(k) Number K172720
Device Name TRACOE silcosoft Tracheostomy Tube
TRACOE medical GmbH
Reichelsheimer Str. 1/3
Nieder-Olm,  DE 55268
Applicant Contact Eva Schaeffer
Capamed Inc.
14 E.Eau Claire St. 447
Rice Lake,  WI  54868
Correspondent Contact Lu Anne Bauer
Regulation Number868.5800
Classification Product Code
Date Received09/08/2017
Decision Date 04/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No