FDA 510(k) Application Details - K120103

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K120103
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	GERARD J PRUD'HOMME 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	01/12/2012
Decision Date	02/03/2012
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