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 |