FDA 510(k) Application Details - K190185

Device Classification Name	More FDA Info for this Device
510(K) Number	K190185
Device Name	Phasix ST Mesh with Open Positioning System
Applicant	C.R. Bard, Inc. 100 Crossings Boulevard Warwick, RI 02886 US Other 510(k) Applications for this Company
Contact	Shirin Mate 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	02/01/2019
Decision Date	06/12/2019
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