FDA 510(k) Application Details - K090472

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K090472
Device Name	Mouthguard, Prescription
Applicant	ARCHTEK, INC. 1705 SOUTH CAPITOL OF TEXAS HW AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	KRISTA OAKES 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	02/24/2009
Decision Date	10/14/2009
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