FDA 510(k) Application Details - K053361

Device Classification Name	More FDA Info for this Device
510(K) Number	K053361
Device Name	MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
Applicant	MPATHY MEDICAL DEVICES, LTD. 150 ARAN HILL ROAD FAIRFIELD, CT 06824-1712 US Other 510(k) Applications for this Company
Contact	LOUIS J MAZZARESE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2005
Decision Date	02/06/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review