FDA 510(k) Application Details - K092207

Device Classification Name	More FDA Info for this Device
510(K) Number	K092207
Device Name	RESTORELLE POLYPROPYLENE MESH
Applicant	MPATHY MEDICAL DEVICES INC 208 WRIGHT BUSINESS CENTRE LONMAY ROAD GLASGOW G33-4EL GB Other 510(k) Applications for this Company
Contact	CAROLINE STRETTON 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	07/22/2009
Decision Date	08/04/2009
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