Y-MIC
FDA 510(k) clearance K161639 · decided 2016-12-22
Clearance details
- K-number
- K161639
- Device name
- Y-MIC
- Applicant
- Micron Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-06-14
- Decision date
- 2016-12-22
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ota-Ku, Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.