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 K926246
Device Name OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
Applicant
Omron Healthcare, Inc.
300 Lakeview Pkwy.
Vernon Hills,  IL  60061
Applicant Contact FRANK BRICHETTO
Correspondent
Omron Healthcare, Inc.
300 Lakeview Pkwy.
Vernon Hills,  IL  60061
Correspondent Contact FRANK BRICHETTO
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received12/14/1992
Decision Date 04/14/1993
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
-
-