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FDA 510(k)

Pixie Skin Tag

K号: K240226 · 2024-10-18

决定日期2024-10-18
产品代码ORE
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决定实质等同

器械摘要

Pixie Skin Tag is the device name listed in this FDA 510(k) record. The listed applicant is Oystershell NV. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K240226. The device is classified under product code ORE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pixie Skin Tag?

Pixie Skin Tag is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Oystershell NV. The 510(k) number is K240226.

When did Pixie Skin Tag receive FDA 510(k) clearance?

Pixie Skin Tag received FDA 510(k) clearance on 2024-10-18, under 510(k) number K240226.

Who is the listed applicant for Pixie Skin Tag?

The FDA 510(k) record lists Oystershell NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pixie Skin Tag?

The FDA product code for Pixie Skin Tag is ORE.

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