FDA 510(k) Application Details - K041416

Device Classification Name	Catheter, Upper Urinary Tract   More FDA Info for this Device
510(K) Number	K041416
Device Name	Catheter, Upper Urinary Tract
Applicant	DEROYAL 200 DEBUSK LN. POWELL, TN 37849 US Other 510(k) Applications for this Company
Contact	SHARON COOK Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/2004
Decision Date	07/02/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review