FDA 510(k) Application Details - K201091

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K201091
Device Name	Mouthguard, Prescription
Applicant	VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven 27472 DE Other 510(k) Applications for this Company
Contact	M. Th. Plaumann 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	04/23/2020
Decision Date	11/06/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review