The following data is part of a premarket notification filed by Cedic S.r.l. with the FDA for Cedic Enteral Enfit Transition Connectors.
| Device ID | K162254 |
| 510k Number | K162254 |
| Device Name: | Cedic Enteral ENFit Transition Connectors |
| Classification | Enteral Specific Transition Connectors |
| Applicant | CEDIC S.R.L. VIA LIBERAZIONE, 63/9 Peschiera Borromeo, IT 20068 |
| Contact | Tiziana Melis |
| Correspondent | Roger Gray DONAWA LIFESCIENCE CONSULTING S.R.L. PIAZZA ALBANIA, 10 Rome, IT 00153 |
| Product Code | PIO |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-10 |
| Decision Date | 2017-05-04 |
| Summary: | summary |