The following data is part of a premarket notification filed by Medimop Medical Project Ltd. with the FDA for Vial2bag Direct Connect.
| Device ID | K170095 |
| 510k Number | K170095 |
| Device Name: | Vial2Bag Direct Connect |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | Medimop Medical Project Ltd. 17 Hatidhar St. Ra'anana, IL 43665 |
| Contact | Ilanit Goldgraber |
| Correspondent | Ilanit Goldgraber Medimop Medical Project Ltd. 17 Hatidhar St. Ra'anana, IL 43665 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-11 |
| Decision Date | 2017-03-08 |
| Summary: | summary |