BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001— 510(k) K032976
Substantially EquivalentBiovalve Technologies, Inc.
FDA 510(k) clearance K032976 for BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001, Substantially Equivalent on 2004-04-16. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Worcester, MA, US
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