FDA 510(k) Application Details - K134015

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K134015
Device Name	Mouthguard, Prescription
Applicant	MERZ DENTAL GMBH 5616 MARIOLA PL NE ALBUQUERQUE, NM 87111 US Other 510(k) Applications for this Company
Contact	RICHARD G HUNTER 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	12/27/2013
Decision Date	04/11/2014
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