FDA 510(k) Application Details - K051503

Device Classification Name	More FDA Info for this Device
510(K) Number	K051503
Device Name	UGYTEX SUAL KNIT MESH
Applicant	SOFRADIM PRODUCTION 5 WHITCOMB AVENUE AYER, MA 01432 US Other 510(k) Applications for this Company
Contact	PAMELA PAPINEAU 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	06/07/2005
Decision Date	08/05/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review