NoCord
FDA 510(k) clearance K152826 · decided 2016-05-27
Clearance details
- K-number
- K152826
- Device name
- NoCord
- Applicant
- Centrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-29
- Decision date
- 2016-05-27
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.