FDA 510(k) Application Details - K122440

Device Classification Name	More FDA Info for this Device
510(K) Number	K122440
Device Name	RESTORELLE L
Applicant	COLOPLAST CORP. 1601 WEST RIVER RD NORTH 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	08/10/2012
Decision Date	11/19/2012
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