FDA 510(k) Application Details - K063229

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K063229
Device Name	Mouthguard, Over-The-Counter
Applicant	RANIR LLC 900 FIFTH THIRD CENTER 111 LYON STREET N.W. GRAND RAPIDS, MI 49503 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER PREDKO 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	10/25/2006
Decision Date	12/19/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review