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/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K180253
Device Name Sheridan Endobronchial Tubes
Applicant
Teleflex Medical
3015 Carrington Mills Blvd
Morrisville,  NC  27560
Applicant Contact Lori Pfohl
Correspondent
Teleflex Medical
3015 Carrington Mills Blvd
Morrisville,  NC  27560
Correspondent Contact Lori Pfohl
Regulation Number868.5740
Classification Product Code
CBI  
Date Received01/30/2018
Decision Date 11/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-