DAMON 4CLEAR— 510(k) K081415
Substantially EquivalentOrmco Corp.
FDA 510(k) clearance K081415 for DAMON 4CLEAR, Substantially Equivalent on 2008-09-24. Applicant: Ormco Corp.. Device class: 2.
Clearance details
- Applicant
- Ormco Corp.
- Product code
- Code NJM
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orange, CA, US
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