FDA 510(k) Application Details - K120160

Device Classification Name	Accessories, Catheter, G-U   More FDA Info for this Device
510(K) Number	K120160
Device Name	Accessories, Catheter, G-U
Applicant	PROMEPLA SAM LE COPORI-9 AVENUE PRINCE ALBERT II MONACO MC 9800 MC Other 510(k) Applications for this Company
Contact	KRISTA JOHNSON Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KNY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2012
Decision Date	05/14/2012
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