FDA 510(k)

Single Use Surgical Suction Irrigator

K-번호: K161421 · 2016-06-24

신청자Jiangsu Haize Medical Scientific Development Co., Ltd.

결정일2016-06-24

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Single Use Surgical Suction Irrigator is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Haize Medical Scientific Development Co., Ltd.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K161421. 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 Single Use Surgical Suction Irrigator?

Single Use Surgical Suction Irrigator is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Jiangsu Haize Medical Scientific Development Co., Ltd.. The 510(k) number is K161421.

When did Single Use Surgical Suction Irrigator receive FDA 510(k) clearance?

Single Use Surgical Suction Irrigator received FDA 510(k) clearance on 2016-06-24, under 510(k) number K161421.

Who is the listed applicant for Single Use Surgical Suction Irrigator?

The FDA 510(k) record lists Jiangsu Haize Medical Scientific Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Surgical Suction Irrigator?

The FDA product code for Single Use Surgical Suction Irrigator is GCJ.

Jiangsu Haize Medical Scientific Development Co., Ltd.를 신청인으로 등재한 기타 기록

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