The following data is part of a premarket notification filed by Cedic S.r.l. with the FDA for Cedic Oral/luer Enteral Enfit Transition Connector For Medication Port.
| Device ID | K150010 |
| 510k Number | K150010 |
| Device Name: | Cedic Oral/Luer Enteral ENFit Transition Connector For Medication Port |
| 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 | 2015-01-02 |
| Decision Date | 2015-04-02 |
| Summary: | summary |