FDA 510(k) Application Details - K191836

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K191836
Device Name	Mouthguard, Prescription
Applicant	Amann Girrbach AG Herrschaftswiesen 1 Koblach 6842 AT Other 510(k) Applications for this Company
Contact	Debora Engel 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	07/09/2019
Decision Date	12/20/2019
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