The following data is part of a premarket notification filed by Cedic S.r.l. with the FDA for Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes.
| Device ID | K181787 |
| 510k Number | K181787 |
| Device Name: | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Cedic S.r.l. Via Liberazione, 63/9 Peschiera Borromeo, IT 20068 |
| Contact | Tiziana Melis |
| Correspondent | Crystal Koelper Koelper Consulting LLC 268 Baltimore Drive North Barrington, ID 60010 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-05 |
| Decision Date | 2019-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056093720822 | K181787 | 000 |
| 08056093720860 | K181787 | 000 |
| 08056093720884 | K181787 | 000 |
| 08056093720907 | K181787 | 000 |
| 08056093720921 | K181787 | 000 |
| 08056093720945 | K181787 | 000 |
| 08056093720969 | K181787 | 000 |
| 08056093720983 | K181787 | 000 |
| 08056093721003 | K181787 | 000 |
| 08056093721027 | K181787 | 000 |
| 08056093721041 | K181787 | 000 |
| 08056093721065 | K181787 | 000 |
| 08056093720761 | K181787 | 000 |
| 08056093720785 | K181787 | 000 |
| 08056093720808 | K181787 | 000 |
| 08056093720846 | K181787 | 000 |