L360 Thigh System— 510(k) K191587
Substantially EquivalentBioness, Inc.
FDA 510(k) clearance K191587 for L360 Thigh System, Substantially Equivalent on 2019-09-12. 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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