The following data is part of a premarket notification filed by Migada Plant with the FDA for Tevadaptor, Closed Drug Reconstitution And Transfer System.
| Device ID | K071741 |
| 510k Number | K071741 |
| Device Name: | TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | MIGADA PLANT NORTH INDUSTRIAL ZONE Kiryat Shmona, IL 10258 |
| Contact | Yossi Shachar |
| Correspondent | Yossi Shachar MIGADA PLANT NORTH INDUSTRIAL ZONE Kiryat Shmona, IL 10258 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-27 |
| Decision Date | 2007-09-24 |
| Summary: | summary |