FDA 510(k) Application Details - K100288

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K100288
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	NEOMED, INC. 717 LAKEGLEN DR. SUWANEE, GA 30024 US Other 510(k) Applications for this Company
Contact	PENNY NORTHCUTT 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	02/01/2010
Decision Date	08/03/2010
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