STARBAND— 510(k) K082950
Substantially EquivalentOrthomerica Products, Inc.
FDA 510(k) clearance K082950 for STARBAND, Substantially Equivalent on 2008-12-05. Applicant: Orthomerica Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthomerica Products, Inc.
- Product code
- Code OAN
- Device class
- Class 2
- Regulation
- 21 CFR 882.5970
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orlando, FL, US
Recent devices under product code OAN
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