CureOs TCP
FDA 510(k) clearance K191670 · decided 2020-08-04
Clearance details
- K-number
- K191670
- Device name
- CureOs TCP
- Applicant
- Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic
- Decision
- Substantially Equivalent
- Date received
- 2019-06-21
- Decision date
- 2020-08-04
- Days to decision
- 410 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ankara, TR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.