FDA 510(k) Application Details - K072951

Device Classification Name	More FDA Info for this Device
510(K) Number	K072951
Device Name	PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
Applicant	SOFRADIM PRODUCTION 150 GLOVER AVENUE NORWALK, CT 06856 US Other 510(k) Applications for this Company
Contact	SHARON ALEXANDER 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	10/18/2007
Decision Date	12/19/2007
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