The following data is part of a premarket notification filed by Covidien with the FDA for Monoject Enteral Syringe With Enfit Connector.
| Device ID | K161963 |
| 510k Number | K161963 |
| Device Name: | Monoject Enteral Syringe With ENFit Connector |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Sona Manickam |
| Correspondent | Sona Manickam COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521545519 | K161963 | 000 |
| 10884521545502 | K161963 | 000 |
| 10884521545496 | K161963 | 000 |
| 10884521545489 | K161963 | 000 |
| 10884521545465 | K161963 | 000 |
| 10884521545403 | K161963 | 000 |