FDA 510(k)

Sterile Auto-Disable Syringes with/without Needle for Single Use

K-번호: K231727 · 2023-09-08

결정일2023-09-08

제품 코드FMF

자문 위원회HO

결정Substantially Equivalent

기기 요약

Sterile Auto-Disable Syringes with/without Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Wepon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231727. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sterile Auto-Disable Syringes with/without Needle for Single Use?

Sterile Auto-Disable Syringes with/without Needle for Single Use is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Wepon Medical Technology Co., Ltd.. The 510(k) number is K231727.

When did Sterile Auto-Disable Syringes with/without Needle for Single Use receive FDA 510(k) clearance?

Sterile Auto-Disable Syringes with/without Needle for Single Use received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231727.

Who is the listed applicant for Sterile Auto-Disable Syringes with/without Needle for Single Use?

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

What is the FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use?

The FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use is FMF.

Wepon Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K231723Sterile Safety Hypodermic Needles for Single Use K231720Sterile Hypodermic Needles for Single Use K231729Sterile syringes for single use with/without needle K212299Medical Surgical Mask

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