The following data is part of a premarket notification filed by Cedic S.r.l. with the FDA for Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector For Medication Port.
| Device ID | K140581 |
| 510k Number | K140581 |
| Device Name: | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT |
| Classification | Enteral Specific Transition Connectors |
| Applicant | CEDIC S.R.L. PIAZZA ALBANIA, 10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray CEDIC 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 | 2014-03-06 |
| Decision Date | 2014-10-17 |
| Summary: | summary |