The following data is part of a premarket notification filed by Valeritas, Inc. with the FDA for V-go Insulin Delivery System.
| Device ID | K103825 |
| 510k Number | K103825 |
| Device Name: | V-GO INSULIN DELIVERY SYSTEM |
| Classification | Pump, Infusion, Insulin |
| Applicant | VALERITAS, INC. 800 BOSTON TURNPIKE Shrewsbury, MA 01545 |
| Contact | Scott Huie |
| Correspondent | Scott Huie VALERITAS, INC. 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 | 2010-12-30 |
| Decision Date | 2011-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385609600033 | K103825 | 000 |
| 10385609600026 | K103825 | 000 |
| 10385609600019 | K103825 | 000 |
| 40385609400030 | K103825 | 000 |
| 00385609400025 | K103825 | 000 |
| 40385609400016 | K103825 | 000 |