510(k) K171131
K171131 is an FDA 510(k) premarket notification submitted by Mazza Healthcare, LLC for the device "MHC Standard and NRFit Tip Syringes". The FDA issued a decision of Substantially Equivalent on Nov 8, 2017. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 8, 2017
- Date Received
- Apr 17, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)