FDA 510(k) Application Details - K082387

Device Classification Name	More FDA Info for this Device
510(K) Number	K082387
Device Name	APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
Applicant	AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD WEST MINNETONKA, MN 55416 US Other 510(k) Applications for this Company
Contact	SARAH PETERSON 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	08/19/2008
Decision Date	12/04/2008
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