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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
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