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 Rinse, Oral, Antibacterial (By Physical Means)
510(k) Number K053166
Device Name SINCLAIR ORAL RINSE
Applicant
Sinclair Pharmaceuticals Limited
Borough Rd.
Godalming, Surrey,  GB
Applicant Contact MICHAEL KILLEEN
Correspondent
Sinclair Pharmaceuticals Limited
Borough Rd.
Godalming, Surrey,  GB
Correspondent Contact MICHAEL KILLEEN
Regulation Number872.5580
Classification Product Code
NTO  
Date Received11/14/2005
Decision Date 05/17/2006
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
-
-