FDA 510(k) Application Details - K122459

Device Classification Name	More FDA Info for this Device
510(K) Number	K122459
Device Name	PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
Applicant	Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	MICHELLE BERRY 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	08/13/2012
Decision Date	12/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review