The following data is part of a premarket notification filed by Xeridiem Medical Devices, A Spectrum Plastics Group Company with the FDA for 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 P.
| Device ID | K180708 |
| 510k 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 P |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Xeridiem Medical Devices, A Spectrum Plastics Group Company 4700 S. Overland Dr. Tucson, AZ 85714 |
| Contact | Steve Murray |
| Correspondent | Steve Murray Xeridiem Medical Devices, A Spectrum Plastics Group Company 4700 S. Overland Dr. Tucson, AZ 85714 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-19 |
| Decision Date | 2018-10-18 |
| Summary: | summary |