MORPHEUS
FDA 510(k) clearance K082249 · decided 2009-12-31
Clearance details
- K-number
- K082249
- Device name
- MORPHEUS
- Applicant
- Meibach Tech Ltda
- Decision
- Substantially Equivalent
- Date received
- 2008-08-08
- Decision date
- 2009-12-31
- Days to decision
- 510 days
- Clearance type
- Abbreviated
- Product code
- EJI
- Device class
- 2
- Regulation number
- 872.6770
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.