FDA 510(k) Application Details - K112386

Device Classification Name	More FDA Info for this Device
510(K) Number	K112386
Device Name	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
Applicant	COLOPLAST CORP. 1601 WEST RIVER 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	OTP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2011
Decision Date	09/08/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review