FDA 510(k) Application Details - K182008

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K182008
Device Name	Mesh, Surgical, Polymeric
Applicant	CR Bard Inc. 100 Crossing Boulevard Warwick, RI 02886 US Other 510(k) Applications for this Company
Contact	Shirin Mate Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2018
Decision Date	12/14/2018
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