FDA 510(k) Application Details - K003956

Device Classification Name	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)   More FDA Info for this Device
510(K) Number	K003956
Device Name	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Applicant	C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 BILLERICA, MA 01821 US Other 510(k) Applications for this Company
Contact	BETH A ZIS Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2000
Decision Date	01/05/2001
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