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 Toothbrush, Powered
510(k) Number K913724
Device Name SONEX ULTRASONIC TOOTH BRUSH
Applicant
Sonex Intl., Corp.
Colonial Sq., Rte. 22
Brewster,  NY  10509
Applicant Contact ROBERT T BOCK
Correspondent
Sonex Intl., Corp.
Colonial Sq., Rte. 22
Brewster,  NY  10509
Correspondent Contact ROBERT T BOCK
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received08/20/1991
Decision Date 12/28/1992
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
-
-