Rotium— 510(k) K250021
Substantially EquivalentNanofiber Solutions, LLC
FDA 510(k) clearance K250021 for Rotium, Substantially Equivalent on 2025-02-27. Applicant: Nanofiber Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Nanofiber Solutions, LLC
- Product code
- Code OWW
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin, OH, US
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