The following data is part of a premarket notification filed by Medimop Medical Projects Ltd. with the FDA for Vented Vial Adapter Transfer Device - 13mm.
| Device ID | K160503 |
| 510k Number | K160503 |
| Device Name: | Vented Vial Adapter Transfer Device - 13mm |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | MEDIMOP MEDICAL PROJECTS LTD. 17 HATIDHAR ST. Ra'anana, IL 4366519 |
| Contact | Ilanit Goldgraber |
| Correspondent | Ilanit Goldgraber MEDIMOP MEDICAL PROJECTS LTD. 17 HATIDHAR ST. Ra'anana, IL 4366519 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-24 |
| Decision Date | 2016-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290108240317 | K160503 | 000 |