FDA 510(k)

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

K-번호: K211571 · 2022-05-31

신청자Zhejiang Longterm Medical Technology Co., Ltd.

결정일2022-05-31

제품 코드OMP

자문 위원회SU

결정Substantially Equivalent

기기 요약

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K211571. 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 Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K211571.

When did Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit receive FDA 510(k) clearance?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit received FDA 510(k) clearance on 2022-05-31, under 510(k) number K211571.

Who is the listed applicant for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

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

What is the FDA product code for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

The FDA product code for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is OMP.

Zhejiang Longterm Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

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