The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Omnifix Low Dead Space Luer Lock Syringe.
| Device ID | K193101 |
| 510k Number | K193101 |
| Device Name: | Omnifix Low Dead Space Luer Lock Syringe |
| Classification | Syringe, Piston |
| Applicant | B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| Contact | Tracy Larish |
| Correspondent | Tracy Larish B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-08 |
| Decision Date | 2020-03-05 |