FDA 510(k) Application Details - K122968

Device Classification Name	More FDA Info for this Device
510(K) Number	K122968
Device Name	NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
Applicant	COLOPLAST CORP. 1601 WEST RIVER N MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	MARGARET BATCHELDER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2012
Decision Date	12/18/2012
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