CHOOSTENT
FDA 510(k) clearance K072094 · decided 2008-09-25
Clearance details
- K-number
- K072094
- Device name
- CHOOSTENT
- Applicant
- M.I.Tech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-30
- Decision date
- 2008-09-25
- Days to decision
- 423 days
- Clearance type
- Traditional
- Product code
- ESW
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Deerfield, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.