The following data is part of a premarket notification filed by Pentaferte Italia S.r.l. with the FDA for Enfit Enteral Pump Syringes Penta Enfit, Enfit Enteral Pump Syringes Nutrifit.
| Device ID | K161141 |
| 510k Number | K161141 |
| Device Name: | ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | PENTAFERTE ITALIA S.R.L. LOC. NOCELLA SP 262 Campli, IT I-64012 |
| Contact | Rosa Di Gioia |
| Correspondent | Rosa Di Gioia Pentaferte, S.R.L. Loc. Nocella SP 262 Campli, IT I-64012 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-22 |
| Decision Date | 2017-03-22 |
| Summary: | summary |