CARRIGEN
FDA 510(k) clearance K100883 · decided 2010-12-21
Clearance details
- K-number
- K100883
- Device name
- CARRIGEN
- Applicant
- Etex Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-30
- Decision date
- 2010-12-21
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- LYC
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.