The following data is part of a premarket notification filed by Mazza Healthcare, Llc. with the FDA for Mhc Standard And Nrfit Tip Syringes.
| Device ID | K171131 |
| 510k Number | K171131 |
| Device Name: | MHC Standard And NRFit Tip Syringes |
| Classification | Syringe, Piston |
| Applicant | Mazza Healthcare, LLC. 2101 Waukegan Road Suite 208 Bannockburn, IL 60015 |
| Contact | Michael A. Mazza |
| Correspondent | Jon Gilbert Jon Gilbert 1641 Jeurissen Lane Chanhassen, MN 55317 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-17 |
| Decision Date | 2017-11-08 |
| Summary: | summary |