BIOVALVE MINI-JECT NEEDLEFREE INJECTOR

Injector, Fluid, Non-electrically Powered

BIOVALVE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Biovalve Technologies, Inc. with the FDA for Biovalve Mini-ject Needlefree Injector.

Pre-market Notification Details

Device IDK051985
510k NumberK051985
Device Name:BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
ClassificationInjector, Fluid, Non-electrically Powered
Applicant BIOVALVE TECHNOLOGIES, INC. 155 FLANDERS RD. Westborough,  MA  01581
ContactScott Huie
CorrespondentScott Huie
BIOVALVE TECHNOLOGIES, INC. 155 FLANDERS RD. Westborough,  MA  01581
Product CodeKZE  
CFR Regulation Number880.5430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-22
Decision Date2005-08-17
Summary:summary

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