FDA 510(k) Application Details - K191320

Device Classification Name	Device, Jaw Repositioning   More FDA Info for this Device
510(K) Number	K191320
Device Name	Device, Jaw Repositioning
Applicant	Slow Wave, Inc. 26100 Countryside Dr. Spicewood, TX 78669 US Other 510(k) Applications for this Company
Contact	Wayne R. Wagner Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	LQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2019
Decision Date	10/02/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review