FDA 510(k)

U&U Insulin Syringe with/without Safety Retractable Device

K-번호: K152808 · 2016-03-25

결정일2016-03-25

제품 코드MEG

자문 위원회HO

결정Substantially Equivalent

기기 요약

U&U Insulin Syringe with/without Safety Retractable Device is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K152808. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the U&U Insulin Syringe with/without Safety Retractable Device?

U&U Insulin Syringe with/without Safety Retractable Device is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K152808.

When did U&U Insulin Syringe with/without Safety Retractable Device receive FDA 510(k) clearance?

U&U Insulin Syringe with/without Safety Retractable Device received FDA 510(k) clearance on 2016-03-25, under 510(k) number K152808.

Who is the listed applicant for U&U Insulin Syringe with/without Safety Retractable Device?

The FDA 510(k) record lists U&U Medical Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U&U Insulin Syringe with/without Safety Retractable Device?

The FDA product code for U&U Insulin Syringe with/without Safety Retractable Device is MEG.

U&U Medical Technology Co, Ltd.를 신청인으로 등재한 기타 기록

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