FDA 510(k) Application Details - K112322

Device Classification Name	More FDA Info for this Device
510(K) Number	K112322
Device Name	RESTORELLE POLYPROPYLENE Y MESH
Applicant	COLOPLAST A/S 1601 WEST RIVER ROAD N MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	TIM CRABTREE 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	08/12/2011
Decision Date	05/17/2012
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