FDA 510(k) Application Details - K091175

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K091175
Device Name	Mouthguard, Over-The-Counter
Applicant	RANIR LLC 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHAN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2009
Decision Date	05/08/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review