TECHFIT Patient-Specific Maxillofacial System
FDA 510(k) clearance K203282 · decided 2021-05-19
Clearance details
- K-number
- K203282
- Device name
- TECHFIT Patient-Specific Maxillofacial System
- Applicant
- Industrias Medicas Sampedro S.A.S
- Decision
- Substantially Equivalent
- Date received
- 2020-11-06
- Decision date
- 2021-05-19
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- La Estrella, CO
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.