The following data is part of a premarket notification filed by Valeritas, Llc with the FDA for V-go Disposable Insulin Delivery Device, Model# V-go 20, V-go 30, V-go40.
| Device ID | K100504 |
| 510k Number | K100504 |
| Device Name: | V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 |
| Classification | Pump, Infusion, Insulin |
| Applicant | VALERITAS, LLC 800 BOSTON TURNPIKE Shrewsbury, MA 01545 |
| Contact | Scott Huie |
| Correspondent | Scott Huie VALERITAS, LLC 800 BOSTON TURNPIKE Shrewsbury, MA 01545 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-22 |
| Decision Date | 2010-12-01 |
| Summary: | summary |