FDA 510(k)

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K-번호: K221400 · 2023-02-09

결정일2023-02-09

제품 코드KNT

자문 위원회규제 정책: medical-regulatory-v1 GU

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기기 요약

hygh-tec drainage is the device name listed in this FDA 510(k) record. The listed applicant is Creative Balloons GmbH. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K221400. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the hygh-tec drainage?

hygh-tec drainage is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Creative Balloons GmbH. The 510(k) number is K221400.

When did hygh-tec drainage receive FDA 510(k) clearance?

hygh-tec drainage received FDA 510(k) clearance on 2023-02-09, under 510(k) number K221400.

Who is the listed applicant for hygh-tec drainage?

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

What is the FDA product code for hygh-tec drainage?

The FDA product code for hygh-tec drainage is KNT.

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기기 요약

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관련 임상시험

관련 기기 (코드: KNT)

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