FDA 510(k) Application Details - K141084

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K141084
Device Name	Mesh, Surgical
Applicant	ACELL, INC 6640 ELI WHITNEY DR SUITE 200 COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	Salman Elmi Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2014
Decision Date	06/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review