The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Phaseal Closed System Transfer Device - P55.
| Device ID | K130197 |
| 510k Number | K130197 |
| Device Name: | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | Becton, Dickinson And Company 1 BECTON DRIVE MC237 Franklin Lakes, NJ 07417 |
| Contact | John Roberts |
| Correspondent | John Roberts Becton, Dickinson And Company 1 BECTON DRIVE MC237 Franklin Lakes, NJ 07417 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-28 |
| Decision Date | 2013-02-27 |
| Summary: | summary |