The following data is part of a premarket notification filed by Biovalve Technologies, Inc. with the FDA for Biovalve Mini-ject Needlefree Injector.
| Device ID | K051985 |
| 510k Number | K051985 |
| Device Name: | BIOVALVE MINI-JECT NEEDLEFREE INJECTOR |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | BIOVALVE TECHNOLOGIES, INC. 155 FLANDERS RD. Westborough, MA 01581 |
| Contact | Scott Huie |
| Correspondent | Scott Huie BIOVALVE TECHNOLOGIES, INC. 155 FLANDERS RD. Westborough, MA 01581 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-22 |
| Decision Date | 2005-08-17 |
| Summary: | summary |