FDA 510(k) Application Details - K190948

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K190948
Device Name	Aligner, Sequential
Applicant	Voodoo Manufacturing, Inc. 361 Stagg Street #408 Brooklyn, NY 112062 US Other 510(k) Applications for this Company
Contact	Max Friefeld Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2019
Decision Date	05/09/2019
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	Y
Expedited Review