FDA 510(k) Application Details - K223907

Device Classification Name	More FDA Info for this Device
510(K) Number	K223907
Device Name	NuEra Tight RF Model APMD145.M70-US
Applicant	BIOS s.r.l. Via Guido Rossa 10/12 Vimodrone 20055 IT Other 510(k) Applications for this Company
Contact	Martina De Iturbe 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	12/28/2022
Decision Date	05/02/2023
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