510(k) K240226
- Device
- Pixie Skin Tag
- Applicant
- Oystershell NV
- 510(k) number
- K240226
- Product code
- ORE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-18
- Date received
- 2024-01-26
- Review panel
- General, Plastic Surgery
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Laurens De Schepper
- Address
- Nijverheidsweg 10 Merelbeke BE 9820 9820
FDA Registration Numbers#
- 3004416964
- 1719513
- 3027153085