510(k) K240226
K240226 is an FDA 510(k) premarket notification submitted by Oystershell NV for the device "Pixie Skin Tag". The FDA issued a decision of Substantially Equivalent on October 18, 2024.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2024
- Date Received
- January 26, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No