The following data is part of a premarket notification filed by Biovalve Technologies, Inc. with the FDA for Biovalve Miniject Needle-free Injection System, Model Fg-01-001.
| Device ID | K032976 |
| 510k Number | K032976 |
| Device Name: | BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | BIOVALVE TECHNOLOGIES, INC. ONE INNOVATION DR. 3 BIOTECH Worcester, MA 01605 |
| Contact | Scott Huie |
| Correspondent | Scott Huie BIOVALVE TECHNOLOGIES, INC. ONE INNOVATION DR. 3 BIOTECH Worcester, MA 01605 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-24 |
| Decision Date | 2004-04-16 |
| Summary: | summary |