FDA 510(k) Application Details - K212399

Device Classification Name	More FDA Info for this Device
510(K) Number	K212399
Device Name	Aveli
Applicant	NC8, Inc. 2570W. El Camino Real, Suite 310 Mountain View, CA 94040 US Other 510(k) Applications for this Company
Contact	Mellissa Viotti Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2021
Decision Date	10/22/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review