DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE— 510(k) K092973
Substantially EquivalentBionen S.A.S.
FDA 510(k) clearance K092973 for DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE, Substantially Equivalent on 2010-10-07. Applicant: Bionen S.A.S.. Device class: 2.
Clearance details
- Applicant
- Bionen S.A.S.
- Product code
- Code IKT
- Device class
- Class 2
- Regulation
- 21 CFR 890.1385
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carmel, IN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.