FDA 510(k) Application Details - K042112

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K042112
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	MARIAN MEDICAL, INC. PO BOX 5193 DESTIN, FL 32540 US Other 510(k) Applications for this Company
Contact	SANDY WINKLER Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2004
Decision Date	01/28/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review