FDA 510(k) Application Details - K083499

Device Classification Name	More FDA Info for this Device
510(K) Number	K083499
Device Name	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
Applicant	COLOPLAST A/S 1499 WEST RIVER ROAD NORTH MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	JANELL A COLLEY 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	11/25/2008
Decision Date	05/08/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review