The following data is part of a premarket notification filed by Simplivia Healthcare Ltd. with the FDA for Chemfort Cstd.
| Device ID | K192866 |
| 510k Number | K192866 |
| Device Name: | Chemfort CSTD |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | Simplivia Healthcare Ltd. North Industrial Zone Kiryat Shmona, IL 1101801 |
| Contact | Itsik Shmueli |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-07 |
| Decision Date | 2020-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37290115921619 | K192866 | 000 |
| 37290115921756 | K192866 | 000 |
| 37290115921879 | K192866 | 000 |
| 37290115921886 | K192866 | 000 |
| 37290115921893 | K192866 | 000 |
| 17290115921868 | K192866 | 000 |
| 37290115921770 | K192866 | 000 |
| 37290115921749 | K192866 | 000 |
| 37290115921701 | K192866 | 000 |
| 37290115921435 | K192866 | 000 |
| 37290115921602 | K192866 | 000 |
| 37290115921626 | K192866 | 000 |
| 37290115921633 | K192866 | 000 |
| 37290115921640 | K192866 | 000 |
| 17290115921714 | K192866 | 000 |