The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Phaseal Optima Closed System Transfer Device.
| Device ID | K181221 |
| 510k Number | K181221 |
| Device Name: | BD PhaSeal Optima Closed System Transfer Device |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Amy Honey |
| Correspondent | Amy Honey Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-11-30 |
| Summary: | summary |