SONIC AIR MM1500 + (MID), MODEL 50400014
FDA 510(k) clearance K081268 · decided 2009-08-10
Clearance details
- K-number
- K081268
- Device name
- SONIC AIR MM1500 + (MID), MODEL 50400014
- Applicant
- Micro-Mega Societe Anonyme
- Decision
- Substantially Equivalent
- Date received
- 2008-05-05
- Decision date
- 2009-08-10
- Days to decision
- 462 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Besancon, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.