FDA 510(k) Application Details - K113552

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K113552
Device Name	Mesh, Surgical, Polymeric
Applicant	Insightra Medical 9200 IRVINE CENTER DR SUITE 200 IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	Wayne Noda 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	12/01/2011
Decision Date	08/23/2012
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