The following data is part of a premarket notification filed by Cedic S.r.l. with the FDA for Enconnect 40 Mm Screw Cap To Enplus Adapter.
| Device ID | K190327 |
| 510k Number | K190327 |
| Device Name: | ENConnect 40 Mm Screw Cap To ENPlus Adapter |
| 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 Biltmore 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 | 2019-02-13 |
| Decision Date | 2019-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056093721072 | K190327 | 000 |