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 Device, Anti-Snoring
510(k) Number K121761
Device Name SOMNOGUARD SP SOFT
Applicant
Tomed Dr. Toussaint GmbH
854 Us Route 3
Holderness,  NH  03245
Applicant Contact SCOTT WHITCOMB
Correspondent
Tomed Dr. Toussaint GmbH
854 Us Route 3
Holderness,  NH  03245
Correspondent Contact SCOTT WHITCOMB
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/15/2012
Decision Date 09/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-