The following data is part of a premarket notification filed by Nordson Efd with the FDA for Xpresse Injection System.
| Device ID | K083583 |
| 510k Number | K083583 |
| Device Name: | XPRESSE INJECTION SYSTEM |
| Classification | Syringe, Piston |
| Applicant | NORDSON EFD 40 CATAMORE BOULEVARD East Providence, RI 02914 |
| Contact | Jeff Pembroke |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-04 |
| Decision Date | 2009-06-30 |
| Summary: | summary |