FDA 510(k) Application Details - K053166

Device Classification Name	Rinse, Oral, Antibacterial (By Physical Means)   More FDA Info for this Device
510(K) Number	K053166
Device Name	Rinse, Oral, Antibacterial (By Physical Means)
Applicant	SINCLAIR PHARMACEUTICALS LIMITED BOROUGH ROAD GODALMING, SURREY GB Other 510(k) Applications for this Company
Contact	MICHAEL KILLEEN Other 510(k) Applications for this Contact
Regulation Number	872.5580   More FDA Info for this Regulation Number
Classification Product Code	NTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2005
Decision Date	05/17/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review