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 Positioner, Tooth, Preformed
510(k) Number K924975
Device Name THE ORTHOTRAINER
Applicant
Myofunctional Research Corp. Pty. , Ltd.
P.O. Box 14
Helensvale, Queensland,  AU 4212
Applicant Contact CHRIS FARRELL
Correspondent
Myofunctional Research Corp. Pty. , Ltd.
P.O. Box 14
Helensvale, Queensland,  AU 4212
Correspondent Contact CHRIS FARRELL
Regulation Number872.5525
Classification Product Code
KMY  
Date Received09/30/1992
Decision Date 07/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-