FDA 510(k)

Rejoni Intrauterine Catheter

K-번호: K222798 · 2022-12-16

결정일2022-12-16

제품 코드LKF

자문 위원회OB

결정Substantially Equivalent

기기 요약

Rejoni Intrauterine Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Rejoni, Inc.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K222798. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Rejoni Intrauterine Catheter?

Rejoni Intrauterine Catheter is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Rejoni, Inc.. The 510(k) number is K222798.

When did Rejoni Intrauterine Catheter receive FDA 510(k) clearance?

Rejoni Intrauterine Catheter received FDA 510(k) clearance on 2022-12-16, under 510(k) number K222798.

Who is the listed applicant for Rejoni Intrauterine Catheter?

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

What is the FDA product code for Rejoni Intrauterine Catheter?

The FDA product code for Rejoni Intrauterine Catheter is LKF.

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Rejoni Intrauterine Catheter

기기 요약

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관련 임상시험

관련 기기 (코드: LKF)

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