FDA 510(k) Application Details - K031809

Device Classification Name	Tray, Fluoride, Disposable   More FDA Info for this Device
510(K) Number	K031809
Device Name	Tray, Fluoride, Disposable
Applicant	PERIO PROTECT LLC 1625 MASSACHUSETTS AVENUE NW; SUITE 300 WASHINGTON, DC 20036-2247 US Other 510(k) Applications for this Company
Contact	DAVID L ROSEN Other 510(k) Applications for this Contact
Regulation Number	872.6870   More FDA Info for this Regulation Number
Classification Product Code	KMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2003
Decision Date	01/23/2004
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