510(k) K170218
K170218 is an FDA 510(k) premarket notification submitted by Vesco Medical, LLC for the device "Vesco Medical NRFit Tip Syringes". The FDA issued a decision of Substantially Equivalent on February 24, 2017. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Vesco Medical, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2017
- Date Received
- January 25, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type