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, Tracheal (W/Wo Connector)
510(k) Number K093135
Device Name VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
Applicant
VENNER MEDICAL (SINGAPORE) PTE LTD
2626 VALLEY VIEW LANE,
SUITE 4
DALLAS,  TX  75234
Applicant Contact JUDY BURTON
Correspondent
VENNER MEDICAL (SINGAPORE) PTE LTD
2626 VALLEY VIEW LANE,
SUITE 4
DALLAS,  TX  75234
Correspondent Contact JUDY BURTON
Regulation Number868.5730
Classification Product Code
BTR  
Date Received10/05/2009
Decision Date 04/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-