The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Plastipak Syringe.
| Device ID | K182589 |
| 510k Number | K182589 |
| Device Name: | BD Plastipak Syringe |
| Classification | Syringe, Piston |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Leslie Robinson-frye |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET, NW Buffalo, MN 55313 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-09-20 |
| Decision Date | 2019-03-14 |