L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)— 510(k) K103343
Substantially EquivalentBioness, Inc.
FDA 510(k) clearance K103343 for L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT), Substantially Equivalent on 2011-04-29. Applicant: Bioness, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioness, Inc.
- Product code
- Code GZI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5810
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valencia, CA, US
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