FDA 510(k) Application Details - K040315

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K040315
Device Name	Mouthguard, Prescription
Applicant	MCI-MYOHEALTH SYSTEMS 26552 TAMPICO PLACE MISSION VIEJO, CA 92691 US Other 510(k) Applications for this Company
Contact	DAVID BALDING 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	02/09/2004
Decision Date	08/27/2004
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