FDA 510(k)

미로3D 상처 매트릭스

K-번호: K223257 · 2022-11-21

결정일2022-11-21

제품 코드KGN

결정대체적으로 동일

기기 요약

Miro3D Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Reprise Biomedical. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K223257. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Miro3D Wound Matrix?

Miro3D Wound Matrix is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Reprise Biomedical. The 510(k) number is K223257.

When did Miro3D Wound Matrix receive FDA 510(k) clearance?

Miro3D Wound Matrix received FDA 510(k) clearance on 2022-11-21, under 510(k) number K223257.

Who is the listed applicant for Miro3D Wound Matrix?

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

What is the FDA product code for Miro3D Wound Matrix?

The FDA product code for Miro3D Wound Matrix is KGN.

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미로3D 상처 매트릭스

기기 요약

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관련 임상시험

관련 기기 (코드: KGN)

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