Xeridiem Medical Devices, A Spectrum Plastics Group Company · Class II · Cleared Oct 18, 2018
| K-number | K180708 |
| Device name | 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 ENFit |
| Applicant | Xeridiem Medical Devices, A Spectrum Plastics Group Company |
| Product code | PIF |
| Device class | Class II |
| Decision date | Oct 18, 2018 |
| Decision | Unknown |
| Regulation | 876.5980 |
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