FDA 510(k) Application Details - K230532

Device Classification Name	Device, Jaw Repositioning   More FDA Info for this Device
510(K) Number	K230532
Device Name	Device, Jaw Repositioning
Applicant	Achaemenid LLC 2318 Main Street Stratford, CT 06615 US Other 510(k) Applications for this Company
Contact	Rachel Miller 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	02/27/2023
Decision Date	07/12/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review