FDA 510(k) Application Details - K181211

Device Classification Name	More FDA Info for this Device
510(K) Number	K181211
Device Name	Human Tecar HCR 1002
Applicant	UNIBELL S.r.l Via Indipendenza, 27 Calco 23885 IT Other 510(k) Applications for this Company
Contact	Mario Scerri 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	05/07/2018
Decision Date	09/10/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review