FDA 510(k) Application Details - K211091

Device Classification Name	More FDA Info for this Device
510(K) Number	K211091
Device Name	Deka Tiac II
Applicant	EL.EN Electronic Engineering Spa VIA Baldanzese 17 Calenzano 50041 IT Other 510(k) Applications for this Company
Contact	Paolo Peruzzi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2021
Decision Date	10/15/2021
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