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 K903510
Device Name MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH
Applicant
Helm Toy Corp.
C/O Follick & Bessich, P.C.
225 Broadway,Suite 500
New York,  NY  10007
Applicant Contact ROBERT L FOLLICK
Correspondent
Helm Toy Corp.
C/O Follick & Bessich, P.C.
225 Broadway,Suite 500
New York,  NY  10007
Correspondent Contact ROBERT L FOLLICK
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received08/03/1990
Decision Date 09/10/1990
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
-
-