HANAROSTENT Trachea/Bronchium (CCC)
FDA 510(k) clearance K201342 · decided 2020-12-31
Clearance details
- K-number
- K201342
- Device name
- HANAROSTENT Trachea/Bronchium (CCC)
- Applicant
- M.I.Tech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-05-20
- Decision date
- 2020-12-31
- Days to decision
- 225 days
- Clearance type
- Traditional
- Product code
- JCT
- Device class
- 2
- Regulation number
- 878.3720
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Pyeongtaek-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.