SPIRO-BALL— 510(k) K053149
Substantially EquivalentLeventon, S.A.
FDA 510(k) clearance K053149 for SPIRO-BALL, Substantially Equivalent on 2005-12-13. Applicant: Leventon, S.A.. Device class: 2.
Clearance details
- Applicant
- Leventon, S.A.
- Product code
- Code BWF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5690
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Esteve Sesrovires, Barcelona, ES
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