FDA 510(k) Application Details - K033310

Device Classification Name	More FDA Info for this Device
510(K) Number	K033310
Device Name	REMEEX SYSTEM FOR URINARY INCONTINENCE
Applicant	SPECIALITIES REMEEX INTERNATIONAL, S.L. 7307 GLOUCHESTER DRIVE EDINA, MN 55435 US Other 510(k) Applications for this Company
Contact	JEFFREY R SHIDEMAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2003
Decision Date	01/15/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review