FDA 510(k)

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle

Номер K: K210991 · 2021-08-26

Дата решения2021-08-26

Код продуктаFMF

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Antmed Co., Ltd.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K210991. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Disposable Sterile Syringe, Disposable Sterile Syringe with Needle?

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Guangdong Antmed Co., Ltd.. The 510(k) number is K210991.

When did Disposable Sterile Syringe, Disposable Sterile Syringe with Needle receive FDA 510(k) clearance?

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle received FDA 510(k) clearance on 2021-08-26, under 510(k) number K210991.

Who is the listed applicant for Disposable Sterile Syringe, Disposable Sterile Syringe with Needle?

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

What is the FDA product code for Disposable Sterile Syringe, Disposable Sterile Syringe with Needle?

The FDA product code for Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is FMF.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Официальный источник

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