The following data is part of a premarket notification filed by Vesco Medical, Llc with the FDA for Vesco Medical Nrfit Tip Syringes.
| Device ID | K170218 |
| 510k Number | K170218 |
| Device Name: | Vesco Medical NRFit Tip Syringes |
| Classification | Syringe, Piston |
| Applicant | Vesco Medical, LLC 692 N. High Street, Suite 205 Columbus, OH 43215 |
| Contact | Chris O'keefe |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-01-25 |
| Decision Date | 2017-02-24 |
| Summary: | summary |