FDA 510(k) Application Details - K191033

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K191033
Device Name	Mouthguard, Over-The-Counter
Applicant	McKeon Products 25460 Guenther Warren, MI 48091 US Other 510(k) Applications for this Company
Contact	Devin Benner 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	04/18/2019
Decision Date	08/05/2019
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