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, tympanostomy
510(k) Number K941407
Device Name TYMPANOSTOMY (VENTILATION) TUBE
Applicant
XOMED-TREACE, INC.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE,  FL  32216 -0980
Applicant Contact ARTHUR A GERTZMAN
Correspondent
XOMED-TREACE, INC.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE,  FL  32216 -0980
Correspondent Contact ARTHUR A GERTZMAN
Regulation Number874.3880
Classification Product Code
ETD  
Date Received03/23/1994
Decision Date 03/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-