Maxima PRO 45L
FDA 510(k) clearance K141576 · decided 2015-05-04
Clearance details
- K-number
- K141576
- Device name
- Maxima PRO 45L
- Applicant
- Kavo DO Brasil Industria E Comercio Ltda
- Decision
- Substantially Equivalent
- Date received
- 2014-06-12
- Decision date
- 2015-05-04
- Days to decision
- 326 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Santa Catarina, BR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.