BIOVALVE MINI-JECT NEEDLEFREE INJECTOR— 510(k) K051985

Name: FDA 510(k) clearance K051985
Creator: U.S. Food and Drug Administration
Published: 2005-08-17

Substantially Equivalent

Biovalve Technologies, Inc.

FDA 510(k) clearance K051985 for BIOVALVE MINI-JECT NEEDLEFREE INJECTOR, Substantially Equivalent on 2005-08-17. Applicant: Biovalve Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Biovalve Technologies, Inc.
Product code: Code KZE
Device class: Class 2
Regulation: 21 CFR 880.5430
Advisory panel: General Hospital
Date received: 2005-07-22
Decision date: 2005-08-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Westborough, MA, US

Download summary PDF View on FDA.gov ↗

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