FDA 510(k) Application Details - K121272

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K121272
Device Name	Mouthguard, Over-The-Counter
Applicant	AKERVALL TECHNOLOGIES INC 5520 STONE VALLEY DRIVE ANN ARBOR, MI 48105 US Other 510(k) Applications for this Company
Contact	SASSA AKERVALL 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	04/27/2012
Decision Date	10/15/2012
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