NaviENT
FDA 510(k) clearance K163439 · decided 2017-09-01
Clearance details
- K-number
- K163439
- Device name
- NaviENT
- Applicant
- Claronav, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-08
- Decision date
- 2017-09-01
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.