FENESTRA HOOK
FDA 510(k) clearance K841359 · decided 1984-07-18
Clearance details
- K-number
- K841359
- Device name
- FENESTRA HOOK
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-02
- Decision date
- 1984-07-18
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- IYL
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.