The following data is part of a premarket notification filed by Artiglass Srl with the FDA for Artiglass Nrfittm Tip L.o.r. Glass Syringes.
| Device ID | K213800 |
| 510k Number | K213800 |
| Device Name: | Artiglass NRFitTM Tip L.O.R. Glass Syringes |
| Classification | Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact |
| Applicant | Artiglass Srl Via Piemonte 13 Due Carrare, IT 35020 |
| Contact | Sabrina Baccarin |
| Correspondent | Sabrina Baccarin Artiglass Srl Via Piemonte 13 Due Carrare, IT 35020 |
| Product Code | QEH |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-06 |
| Decision Date | 2022-05-19 |