The following data is part of a premarket notification filed by Intervene Group Limited with the FDA for Dash 3 Enfit Syringe, Dash 3 Eccentric Enfit Syringe, Dash 3 Plus Enfit Syringe, Dash 3 Plus Eccentric Enfit Syringe, Dash 3 Enfit Low Dose Tip Syringe.
| Device ID | K170371 |
| 510k Number | K170371 |
| Device Name: | DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | INTERVENE Group Limited Russell Building, Brunel Science Park, Kingston Lane Uxbridge, GB Ub8 3pq |
| Contact | Homer Trieu |
| Correspondent | Homer Trieu INTERVENE Group Limited Russell Building, Brunel Science Park, Kingston Lane Uxbridge, GB Ub8 3pq |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-06 |
| Decision Date | 2017-10-20 |
| Summary: | summary |