FDA 510(k) Application Details - K181893

Device Classification Name	More FDA Info for this Device
510(K) Number	K181893
Device Name	T-PLUS
Applicant	Wintecare SA Via Livio 12 Chiasso 6830 CH Other 510(k) Applications for this Company
Contact	Claudio Freti 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	07/13/2018
Decision Date	01/29/2019
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