The following data is part of a premarket notification filed by B. Braun Medical Ag with the FDA for Omnican Syringe.
| Device ID | K962084 |
| 510k Number | K962084 |
| Device Name: | OMNICAN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | B. BRAUN MEDICAL AG 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN MEDICAL AG 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-29 |
| Decision Date | 1997-02-10 |
| Summary: | summary |