PROPEL device
FDA 510(k) clearance K150392 · decided 2015-09-18
Clearance details
- K-number
- K150392
- Device name
- PROPEL device
- Applicant
- Propel Orthodontics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-02-18
- Decision date
- 2015-09-18
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- DZJ
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Milpitas, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.