FDA 510(k) Application Details - K011149

Device Classification Name	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula   More FDA Info for this Device
510(K) Number	K011149
Device Name	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Applicant	THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE MELVILLE, NY 11747-3157 US Other 510(k) Applications for this Company
Contact	LAURA STOMS-TYLER Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2001
Decision Date	05/15/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review