MINI L.E.D. OEM MODULE
FDA 510(k) clearance K040808 · decided 2004-04-28
Clearance details
- K-number
- K040808
- Device name
- MINI L.E.D. OEM MODULE
- Applicant
- Satelec
- Decision
- Substantially Equivalent
- Date received
- 2004-03-29
- Decision date
- 2004-04-28
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- EBZ
- Device class
- 2
- Regulation number
- 872.6070
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Wellesley, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.