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 K200761
Device Name Tenax Laser Resistant Endotracheal Tube
Applicant
Bryan Medical, Inc.
5725 Dragon Way, Suite 300
Cincinnati,  OH  45227
Applicant Contact Andrew J. Georgilis
Correspondent
AlvaMed, Inc.
1116 Great Plain Avenue, Suite 1
Needham,  MA  02492
Correspondent Contact Ian Broome
Regulation Number868.5730
Classification Product Code
BTR  
Subsequent Product Code
BSK  
Date Received03/24/2020
Decision Date 11/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-