FDA 510(k)

Suction Irrigation Set

K-번호: K172794 · 2017-11-29

신청자Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd

결정일2017-11-29

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Suction Irrigation Set is the device name listed in this FDA 510(k) record. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172794. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Suction Irrigation Set?

Suction Irrigation Set is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. The 510(k) number is K172794.

When did Suction Irrigation Set receive FDA 510(k) clearance?

Suction Irrigation Set received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172794.

Who is the listed applicant for Suction Irrigation Set?

The FDA 510(k) record lists Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Suction Irrigation Set?

The FDA product code for Suction Irrigation Set is GCJ.

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