The following data is part of a premarket notification filed by Valmed Srl with the FDA for Empty Eva Bag, Models Fvm0134bp, Fvm0135bp, Fvm0136bp, Fvm0137bp, Fvm0138bp, Fvm0139bp, Fvm0140bp, Fvm0141bp.
| Device ID | K181393 |
| 510k Number | K181393 |
| Device Name: | Empty Eva Bag, Models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP |
| Classification | Container, I.v. |
| Applicant | VALMED SRL Via Dell'Industria 3 Tovo Di Sant'agata, IT 23030 |
| Contact | Parravicini Christian |
| Correspondent | Tiziana Baggio Studio Baggio Tiziana Via Marzia 9 Abano Terme, IT 35031 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-29 |
| Decision Date | 2019-02-15 |
| Summary: | summary |