FDA 510(k) Application Details - K151933

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K151933
Device Name	Mouthguard, Prescription
Applicant	12TH MAN TECHNOLOGIES, INC. 7245 GARDEN GROVE BLVD., SUITE C GARDEN GROVE, CA 92841 US Other 510(k) Applications for this Company
Contact	ALEX STENZLER 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	07/14/2015
Decision Date	12/10/2015
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