FDA 510(k) Application Details - K030832

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K030832
Device Name	Mouthguard, Prescription
Applicant	COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 CHICAGO, IL 60611 US Other 510(k) Applications for this Company
Contact	MICHAEL O'MALLEY 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	03/17/2003
Decision Date	09/17/2003
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