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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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)
De Novo Number DEN050001
510(K) Number K041482
Device Name DECAPINOL ORAL RINSE
Requester
SINCLAIR PHARMACEUTICALS LIMITED
borough road
godalming,  GB
Contact michael killeen
Regulation Number872.5580
Classification Product Code
NTO  
Date Received01/24/2005
Decision Date 04/18/2005
Decision granted (DENG)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Reclassification Order Reclassification Order
Type Post-NSE
-
-