The following data is part of a premarket notification filed by Simplivia Healthcare Ltd. with the FDA for Tevadaptor Bag Adaptor Ll, Tevadaptor Bag Adaptor Ll With Ultrasite, Tevadaptor Bag Adaptor Sp With Ultrasite, Tevadaptor Iv Secondary Safety Set With Ultrasite, Tevadaptor Iv Secondary Safety Set.
| Device ID | K201142 |
| 510k Number | K201142 |
| Device Name: | TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL With ULTRASITE, TEVADAPTOR Bag Adaptor SP With ULTRASITE, TEVADAPTOR IV Secondary Safety Set With ULTRASITE, TEVADAPTOR IV Secondary Safety Set |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | Simplivia Healthcare Ltd. North Industrial Zone Kiryat Shmona, IL 1011801 |
| Contact | Shay Shaham |
| Correspondent | Shay Shaham Simplivia Healthcare Ltd. North Industrial Zone Kiryat Shmona, IL 1011801 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-29 |
| Decision Date | 2021-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290115921653 | K201142 | 000 |
| 17290115921462 | K201142 | 000 |
| 17290115921455 | K201142 | 000 |
| 17290115921424 | K201142 | 000 |
| 17290115921400 | K201142 | 000 |