FDA 510(k) Application Details - K162828

Device Classification Name	More FDA Info for this Device
510(K) Number	K162828
Device Name	Winback Back 3SE
Applicant	WINBACK USA CORP 302 HIGH PLAINS DR DRIPPING SPRINGS, TX 78620 US Other 510(k) Applications for this Company
Contact	CHEICK KONGO 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	10/07/2016
Decision Date	09/18/2017
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