FDA 510(k) Application Details - K111828

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K111828
Device Name	Mouthguard, Prescription
Applicant	ASTRON DENTAL CORPORATION 815 OAKWOOD RD. UNIT G LAKE ZURICH, IL 60047 US Other 510(k) Applications for this Company
Contact	DOUGLAS S MULLER 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	06/28/2011
Decision Date	10/26/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review