FIREFLY® Midline Navigation Guide— 510(k) K181883
Substantially EquivalentMighty Oak Medical, Inc.
FDA 510(k) clearance K181883 for FIREFLY® Midline Navigation Guide, Substantially Equivalent on 2018-10-03. Applicant: Mighty Oak Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Mighty Oak Medical, Inc.
- Product code
- Code PQC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
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