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 Tube, Tracheostomy (W/Wo Connector)
510(k) Number K781729
Device Name TRACHEOTOMY TUBES
Applicant
TRACOE MEDICAL GMBH
AM SCHLOSS, 20
D 6367 KARBEN 2,  DE
Correspondent
TRACOE MEDICAL GMBH
AM SCHLOSS, 20
D 6367 KARBEN 2,  DE
Regulation Number868.5800
Classification Product Code
BTO  
Date Received10/10/1978
Decision Date 10/24/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-