The following data is part of a premarket notification filed by Intervene Group Ltd with the FDA for Dash 6 Nrfit Lock Syringe + Accessories, Dash 6 Nrfit Slip Syringe + Accessories, Dash 6 Nrfit Plastic Lor Syringe + Accessories.
| Device ID | K170900 |
| 510k Number | K170900 |
| Device Name: | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories |
| Classification | Syringe, Piston |
| Applicant | INTERVENE Group Ltd Russell Building, Brunel Science Park, Kingston Lane Uxbridge, GB Ub8 3pq |
| Contact | Homer Trieu |
| Correspondent | Homer Trieu The Weinberg Group Inc. Russell Building, Brunel Science Park, Kingston Lane Uxbridge, GB Ub8 3pq |
| Product Code | FMF |
| Subsequent Product Code | BSN |
| Subsequent Product Code | BSO |
| Subsequent Product Code | BSP |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-27 |
| Decision Date | 2017-11-09 |
| Summary: | summary |