The following data is part of a premarket notification filed by Xeridiem Medical Devices with the FDA for Bi-funnel And Tri-funnel Gastrostomy Feeding Tubes With Enfit Connection, Entuit Gastrostomy Br Balloon Retention Feeding Tube With Enfit Connection.
| Device ID | K171347 |
| 510k Number | K171347 |
| Device Name: | Bi-Funnel And Tri-Funnel Gastrostomy Feeding Tubes With ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube With ENFit Connection |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Xeridiem Medical Devices 4700 S. Overland Dr. Tucson, AZ 85714 |
| Contact | Steve Murray |
| Correspondent | Steve Murray Xeridiem Medical Devices 4700 S. Overland Dr. Tucson, AZ 85714 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-08 |
| Decision Date | 2017-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813939025170 | K171347 | 000 |
| 00813939025163 | K171347 | 000 |
| 00813939025156 | K171347 | 000 |
| 00813939025149 | K171347 | 000 |
| 00813939025132 | K171347 | 000 |
| 00813939025125 | K171347 | 000 |
| 00813939025118 | K171347 | 000 |