FDA 510(k) Application Details - K202974

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K202974
Device Name	Mouthguard, Over-The-Counter
Applicant	Medtech Products, Inc. 660 White Plains Rd. Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	Vincent Argiro 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	09/30/2020
Decision Date	12/22/2020
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