BI-3M NEEDLE-FREE INJECTOR SYSTEM— 510(k) K013256
Substantially EquivalentFelton International, Inc.
FDA 510(k) clearance K013256 for BI-3M NEEDLE-FREE INJECTOR SYSTEM, Substantially Equivalent on 2001-12-07. Applicant: Felton International, Inc.. Device class: 2.
Clearance details
- Applicant
- Felton International, 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
- Lenexa, KS, US
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