FDA 510(k) Application Details - K133037

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K133037
Device Name	Mouthguard, Over-The-Counter
Applicant	GRIND GUARD TECHNOLOGIES, LLC 342 E. MAIN STREET SUITE 207 LEOLA, PA 17540 US Other 510(k) Applications for this Company
Contact	WILLIAM G MCLAIN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2013
Decision Date	01/23/2014
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