The following data is part of a premarket notification filed by Artiglass Srl with the FDA for Artiglass L. O.r. Glass Syringe.
| Device ID | K122416 |
| 510k Number | K122416 |
| Device Name: | ARTIGLASS L. O.R. GLASS SYRINGE |
| Classification | Syringe, Piston |
| Applicant | ARTIGLASS SRL VIA PIEMONTE 13 Due Carrare Padova, IT 35020 |
| Contact | Federico Baccarin |
| Correspondent | Federico Baccarin ARTIGLASS SRL VIA PIEMONTE 13 Due Carrare Padova, IT 35020 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-08 |
| Decision Date | 2013-05-03 |
| Summary: | summary |