The following data is part of a premarket notification filed by Biogen with the FDA for Syringe Grip For The Avonex Pre-filled Syringe.
| Device ID | K042314 |
| 510k Number | K042314 |
| Device Name: | SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE |
| Classification | Syringe, Piston |
| Applicant | BIOGEN 14 CAMBRIDGE CENTER Cambridge, MA 02142 |
| Contact | Victor J Gangi |
| Correspondent | Victor J Gangi BIOGEN 14 CAMBRIDGE CENTER Cambridge, MA 02142 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-26 |
| Decision Date | 2004-11-22 |
| Summary: | summary |