LUXABITE— 510(k) K013236
Substantially EquivalentDmg USA, Inc.
FDA 510(k) clearance K013236 for LUXABITE, Substantially Equivalent on 2001-10-17. Applicant: Dmg USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Dmg USA, Inc.
- Product code
- Code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Ayer, MA, US
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