FDA 510(k) Application Details - K142989

Device Classification Name	More FDA Info for this Device
510(K) Number	K142989
Device Name	Mini ONE Enteral Extension Set
Applicant	APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD BRECKSVILLE, OH 44141 US Other 510(k) Applications for this Company
Contact	Joshua Meinke Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2014
Decision Date	01/29/2015
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