FDA 510(k) Application Details - K210867

Device Classification Name	More FDA Info for this Device
510(K) Number	K210867
Device Name	NuEra Tight RF, NuEra Tight RF Plus
Applicant	BIOS s.r.l. Via Guido Rossa 10/12 Vimodrone 20090 IT Other 510(k) Applications for this Company
Contact	Eliana Russo 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	03/23/2021
Decision Date	04/21/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review