FDA 510(k)

Sterilization Package/Reel

Номер K: K241565 · 2025-02-24

ЗаявительAnqing Clean Dental Instrument Technology Co., Ltd.

Дата решения2025-02-24

Код продуктаFRG

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Sterilization Package/Reel is the device name listed in this FDA 510(k) record. The listed applicant is Anqing Clean Dental Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-24 under 510(k) number K241565. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Sterilization Package/Reel?

Sterilization Package/Reel is a medical device that received FDA 510(k) clearance on 2025-02-24. The listed applicant is Anqing Clean Dental Instrument Technology Co., Ltd.. The 510(k) number is K241565.

When did Sterilization Package/Reel receive FDA 510(k) clearance?

Sterilization Package/Reel received FDA 510(k) clearance on 2025-02-24, under 510(k) number K241565.

Who is the listed applicant for Sterilization Package/Reel?

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

What is the FDA product code for Sterilization Package/Reel?

The FDA product code for Sterilization Package/Reel is FRG.

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: FRG)

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLC K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Официальный источник

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