FDA 510(k) Application Details - K061122

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K061122
Device Name	Mouthguard, Prescription
Applicant	ALPINE ORAL CARE, LLC 4003 LEELAND HOUSTON, TX 77003 US Other 510(k) Applications for this Company
Contact	CATHY TENG Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2006
Decision Date	03/12/2007
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