FDA 510(k) Application Details - K100173

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K100173
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	SAINATH INTELLECTUAL PROPERTIES, LLC 9438 PEBBLE BEACH CT. WEST LARGO, FL 33777 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER PARADIES 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	01/21/2010
Decision Date	04/16/2010
Decision	SESK - SUBST EQUIV - KIT
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