FDA 510(k) Application Details - K062341

Device Classification Name	More FDA Info for this Device
510(K) Number	K062341
Device Name	MALE REMEEX SYSTEM
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	OTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2006
Decision Date	11/02/2006
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