FDA 510(k) Application Details - K232046

Device Classification Name	More FDA Info for this Device
510(K) Number	K232046
Device Name	Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
Applicant	Xeridiem Medical Devices, A Spectrum Plastics Group Company 4700 S. Overland Dr. Tucson, AZ 85714 US Other 510(k) Applications for this Company
Contact	Steve Murray 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	07/10/2023
Decision Date	10/06/2023
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