FDA 510(k) Application Details - K143623

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K143623
Device Name	Mouthguard, Prescription
Applicant	RESMED SAS 292, ALLEE JACQUES, MONOD SAINT-PRIEST CEDEX 69791 FR Other 510(k) Applications for this Company
Contact	Larissa D'Andrea 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	12/22/2014
Decision Date	08/13/2015
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