The following data is part of a premarket notification filed by Aea Srl with the FDA for S Dispensing Line.
| Device ID | K192770 |
| 510k Number | K192770 |
| Device Name: | S Dispensing Line |
| Classification | Syringe, Piston |
| Applicant | AEA Srl via Fiume 16 Angeli Di Rosora, IT 60030 |
| Contact | Michele Mengoni |
| Correspondent | Michele Mengoni AEA Srl via Fiume 16 Angeli Di Rosora, IT 60030 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-12-17 |