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 Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
510(k) Number K822367
Device Name TOTAL
Applicant
Treace Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Treace Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number874.3495
Classification Product Code
LBN  
Date Received08/06/1982
Decision Date 09/07/1982
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
Predetermined Change
Control Plan Authorized		 No
-
-