Device Listing 1946410398

Listing Summary#

Listing key
1946410398
Premarket submission
K180708
Device
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
Decision date
2018-10-18