FDA 510(k)

시트릭 컴플리트 드라이 시트릭 아시드 (45X)

K-번호: K171750 · 2018-03-06

결정일2018-03-06

제품 코드KPO

자문 위원회규제 정책: medical-regulatory-v1 GU

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기기 요약

Citric Complete Dry Citric Acid (45X) is the device name listed in this FDA 510(k) record. The listed applicant is Dimesol USA, LLC. It received FDA 510(k) clearance on 2018-03-06 under 510(k) number K171750. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Citric Complete Dry Citric Acid (45X)?

Citric Complete Dry Citric Acid (45X) is a medical device that received FDA 510(k) clearance on 2018-03-06. The listed applicant is Dimesol USA, LLC. The 510(k) number is K171750.

When did Citric Complete Dry Citric Acid (45X) receive FDA 510(k) clearance?

Citric Complete Dry Citric Acid (45X) received FDA 510(k) clearance on 2018-03-06, under 510(k) number K171750.

Who is the listed applicant for Citric Complete Dry Citric Acid (45X)?

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

What is the FDA product code for Citric Complete Dry Citric Acid (45X)?

The FDA product code for Citric Complete Dry Citric Acid (45X) is KPO.

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관련 기기 (코드: KPO)

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