The following data is part of a premarket notification filed by Teva Medical Ltd., Migada Plant with the FDA for Tevadaptor Closed Drug Reconstitution And Transfer System.
| Device ID | K180489 |
| 510k Number | K180489 |
| Device Name: | TEVADAPTOR Closed Drug Reconstitution And Transfer System |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | Teva Medical Ltd., Migada Plant North Industrial Zone Kiryat Shmona, IL 10258 |
| Contact | Nadav Reuben |
| Correspondent | Roger Gray Donawa Lifescience Consulting Piazza Albania 10 Rome, IT 00153 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-23 |
| Decision Date | 2018-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290115921233 | K180489 | 000 |
| 17290115921813 | K180489 | 000 |