FDA 510(k) Application Details - K240463

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K240463
Device Name	Mouthguard, Prescription
Applicant	Slow Wave Inc. 26100 Countryside Dr. Spicewood, TX 78669 US Other 510(k) Applications for this Company
Contact	Sam Murray 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	02/16/2024
Decision Date	06/04/2024
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