The following data is part of a premarket notification filed by Biogen with the FDA for Invisiject Resusable Auto-injector.
| Device ID | K032425 |
| 510k Number | K032425 |
| Device Name: | INVISIJECT RESUSABLE AUTO-INJECTOR |
| Classification | Introducer, Syringe Needle |
| Applicant | BIOGEN 14 CAMBRIDGE CENTER Cambridge, MA 02142 |
| Contact | Michael Poirier |
| Correspondent | Michael Poirier BIOGEN 14 CAMBRIDGE CENTER Cambridge, MA 02142 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-06 |
| Decision Date | 2003-11-05 |
| Summary: | summary |