FDA 510(k) Application Details - K070913

Device Classification Name	Anoscope And Accessories   More FDA Info for this Device
510(K) Number	K070913
Device Name	Anoscope And Accessories
Applicant	SAPIMED S.P.A. 1676 VILLAGE GREEN, SUITE A CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E J SMITH Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FER Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2007
Decision Date	08/10/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review