FDA 510(k) Application Details - K192636

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K192636
Device Name	Mesh, Surgical, Polymeric
Applicant	Medtronic, Inc. 8200 Coral Sea St NE Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	Nancy Cameron 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	09/23/2019
Decision Date	04/08/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review