FDA 510(k) Applications Submitted by Xeridiem Medical Devices, A Spectrum Plastics Group Company

FDA 510(k) Number	Submission Date	Device Name	Applicant
K180708	03/19/2018	Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profi	Xeridiem Medical Devices, A Spectrum Plastics Group Company
K232046	07/10/2023	Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection	Xeridiem Medical Devices, A Spectrum Plastics Group Company