FDA 510(k) Application Details - K091880

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K091880
Device Name	Mouthguard, Prescription
Applicant	ASCENTIA HEALTH INCORPORATED 8473 RIPPLED CREEK COURT SPRINGFIELD, VA 22153 US Other 510(k) Applications for this Company
Contact	ROGER WIXTROM 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	06/24/2009
Decision Date	02/24/2010
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