Pixie Skin Tag— 510(k) K240226

Substantially Equivalent

Oystershell NV

FDA 510(k) clearance K240226 for Pixie Skin Tag, Substantially Equivalent on 2024-10-18. Applicant: Oystershell NV.

Clearance details

Applicant: Oystershell NV
Product code: Code ORE
Advisory panel: General, Plastic Surgery
Date received: 2024-01-26
Decision date: 2024-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Merelbeke, BE

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