The following data is part of a premarket notification filed by Haemotronic S.p.a. with the FDA for Empty Eva Bag.
| Device ID | K210749 |
| 510k Number | K210749 |
| Device Name: | Empty EVA Bag |
| Classification | Container, I.v. |
| Applicant | Haemotronic S.p.a. Via Carreri 16 Mirandola, IT 41037 |
| Contact | Franciosi Paola |
| Correspondent | Paola Franciosi Haemotronic S.p.a. Via Carreri 16 Mirandola, IT 41037 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-12 |
| Decision Date | 2021-08-19 |