MEGA ISQ— 510(k) K132401
Substantially EquivalentOsstell AB
FDA 510(k) clearance K132401 for MEGA ISQ, Substantially Equivalent on 2014-04-09. Applicant: Osstell AB. Device class: 1.
Clearance details
- Applicant
- Osstell AB
- Product code
- Code EKX
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alexandria, VA, US
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