The following data is part of a premarket notification filed by West Pharma Services Il, Ltd. with the FDA for Vented Vial Adapter 20mm.
| Device ID | K213513 |
| 510k Number | K213513 |
| Device Name: | Vented Vial Adapter 20mm |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | West Pharma Services IL, Ltd. 4 Hasheizaf St Ra'anana, IL 4366411 |
| Contact | Llanit Goldgraber |
| Correspondent | Fred Cowdery West Pharmaceutical Services, Inc. 530 Hermon O. West Drive Exton, PA 19341 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-02 |
| Decision Date | 2022-08-31 |