The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Phaseal Closed System Transfer Device - Injector.
| Device ID | K140591 |
| 510k Number | K140591 |
| Device Name: | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | BECTON DICKINSON & CO. 1 BECTON DR. MC237 Franklin Lakes, NJ 07417 -1885 |
| Contact | John Roberts |
| Correspondent | John Roberts BECTON DICKINSON & CO. 1 BECTON DR. MC237 Franklin Lakes, NJ 07417 -1885 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-07 |
| Decision Date | 2014-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382905150031 | K140591 | 000 |
| 50382905150017 | K140591 | 000 |