FDA 510(k) Application Details - K091070

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K091070
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	SIERRA SCIENTIFIC INSTRUMENTS, INC. 5757 CENTURY BLVD. SUITE 660 LOS ANGELES, CA 90045 US Other 510(k) Applications for this Company
Contact	REIC S FINKELMAN Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	FFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2009
Decision Date	05/19/2009
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	Y
Expedited Review