FDA 510(k) Application Details - K232966

Device Classification Name	More FDA Info for this Device
510(K) Number	K232966
Device Name	FISIOWARM 7.0
Applicant	Golden Star Srl Via Enrico Pallini 9 Roma 00149 IT Other 510(k) Applications for this Company
Contact	Tiziaria Borrelli 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	09/21/2023
Decision Date	12/26/2024
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