FDA 510(k) Application Details - K100526

Device Classification Name	Tube, Feeding   More FDA Info for this Device
510(K) Number	K100526
Device Name	Tube, Feeding
Applicant	KENTEC MEDICAL, INC. 17871 FITCH IRVINE, CA 92614-6001 US Other 510(k) Applications for this Company
Contact	KEITH ROOKS Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	FPD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2010
Decision Date	04/22/2010
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