The following data is part of a premarket notification filed by Medimop Medical Projects, Ltd. with the FDA for Mix2vial Transfer Device.
| Device ID | K031861 |
| 510k Number | K031861 |
| Device Name: | MIX2VIAL TRANSFER DEVICE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | MEDIMOP MEDICAL PROJECTS, LTD. MITZPE AVIV, INDUSTRIAL PK 13 M.p. Misgav, IL 20187 |
| Contact | Benny Arazy |
| Correspondent | Benny Arazy MEDIMOP MEDICAL PROJECTS, LTD. MITZPE AVIV, INDUSTRIAL PK 13 M.p. Misgav, IL 20187 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-16 |
| Decision Date | 2003-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290108240997 | K031861 | 000 |
| 27290108240263 | K031861 | 000 |
| 27290108240379 | K031861 | 000 |
| 27290108240386 | K031861 | 000 |
| 27290108240393 | K031861 | 000 |
| 27290108240409 | K031861 | 000 |
| 27290108240423 | K031861 | 000 |
| 27290108240539 | K031861 | 000 |
| 27290108240546 | K031861 | 000 |
| 27290108240676 | K031861 | 000 |
| 27290108240690 | K031861 | 000 |
| 27290108240768 | K031861 | 000 |
| 27290108240805 | K031861 | 000 |
| 27290108240812 | K031861 | 000 |
| 27290108240867 | K031861 | 000 |
| 07290108240771 | K031861 | 000 |