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 K061199
Device Name ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
Applicant
Braun GmbH
800 Boylston St.
Prudential Tower Bldg. Floor 46
Boston,  MA  02199 -8004
Applicant Contact AMANDA HEFFERNAN
Correspondent
Braun GmbH
800 Boylston St.
Prudential Tower Bldg. Floor 46
Boston,  MA  02199 -8004
Correspondent Contact AMANDA HEFFERNAN
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received04/28/2006
Decision Date 05/31/2006
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
-
-