FDA 510(k) Application Details - K181005

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K181005
Device Name	Mouthguard, Over-The-Counter
Applicant	Boyd Research, Inc. 506 Pacific Ave Solana Beach, CA 92075 US Other 510(k) Applications for this Company
Contact	James Boyd 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	04/16/2018
Decision Date	01/15/2020
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