FDA 510(k)

Foryou NPWT Dressing Kit

K-번호: K190119 · 2019-11-01

결정일2019-11-01

제품 코드OMP

자문 위원회SU

결정Substantially Equivalent

기기 요약

Foryou NPWT Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is 4l Health Co., Ltd.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K190119. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Foryou NPWT Dressing Kit?

Foryou NPWT Dressing Kit is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is 4l Health Co., Ltd.. The 510(k) number is K190119.

When did Foryou NPWT Dressing Kit receive FDA 510(k) clearance?

Foryou NPWT Dressing Kit received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190119.

Who is the listed applicant for Foryou NPWT Dressing Kit?

The FDA 510(k) record lists 4l Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Foryou NPWT Dressing Kit?

The FDA product code for Foryou NPWT Dressing Kit is OMP.

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Foryou NPWT Dressing Kit

기기 요약

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관련 임상시험

관련 기기 (코드: OMP)

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