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Xeridiem Medical Devices, A Spectrum Plastics Group Company

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories1
Latest FDA decision2023-10-06
TypeNumberDevice NameCodeDateActions
510(k) K232046 Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT ConnectionPIF2023-10-06 View
510(k) K180708 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 Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFitPIF2018-10-18 View