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 Applicator, Absorbent Tipped, Non-Sterile
510(k) Number K870762
Device Name EAR APPLICATOR, CATALOG NO. 2229
Applicant
TREACE MEDICAL, INC.
SUITE 400
22 NORTH SECOND STREET
MEMPHIS,  TN  38103
Applicant Contact THOMAS, JR
Correspondent
TREACE MEDICAL, INC.
SUITE 400
22 NORTH SECOND STREET
MEMPHIS,  TN  38103
Correspondent Contact THOMAS, JR
Regulation Number880.6025
Classification Product Code
KXF  
Date Received02/26/1987
Decision Date 03/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-