The following data is part of a premarket notification filed by Simplivia Healthcare Ltd. with the FDA for Onguard2 Chemfort Closed Administration (cadm).
| Device ID | K210707 |
| 510k Number | K210707 |
| Device Name: | OnGuard2 Chemfort Closed Administration (CADM) |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | Simplivia Healthcare LTD. North Industrial Zone Kiryat Shmona, IL 1101801 |
| Contact | Shay Shaham |
| Correspondent | Shay Shaham Simplivia Healthcare LTD. North Industrial Zone Kiryat Shmona, IL 1101801 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-10 |
| Decision Date | 2021-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290115921684 | K210707 | 000 |
| 17290115921677 | K210707 | 000 |
| 37290115921695 | K210707 | 000 |
| 37290115921664 | K210707 | 000 |