FDA 510(k) Application Details - K181094

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K181094
Device Name	Mesh, Surgical, Polymeric
Applicant	lntegra LifeSciences 1100 Campus Road Princeton, NJ 08540 US Other 510(k) Applications for this Company
Contact	Kendall L. Ciriaco 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	04/25/2018
Decision Date	08/02/2018
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