FDA 510(k) Application Details - K143380

Device Classification Name	More FDA Info for this Device
510(K) Number	K143380
Device Name	Phasix ST Mesh
Applicant	C. R. Bard Inc 100 Crossing Boulevard Warwick, RI 02886 US Other 510(k) Applications for this Company
Contact	Tony John Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2014
Decision Date	06/05/2015
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