FDA 510(k)

SEJONG Surgical Gown Soft

Номер K: K220435 · 2023-02-10

Дата решения2023-02-10

Код продуктаFYA

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

SEJONG Surgical Gown Soft is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K220435. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the SEJONG Surgical Gown Soft?

SEJONG Surgical Gown Soft is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Sejong Healthcare Co., Ltd.. The 510(k) number is K220435.

When did SEJONG Surgical Gown Soft receive FDA 510(k) clearance?

SEJONG Surgical Gown Soft received FDA 510(k) clearance on 2023-02-10, under 510(k) number K220435.

Who is the listed applicant for SEJONG Surgical Gown Soft?

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

What is the FDA product code for SEJONG Surgical Gown Soft?

The FDA product code for SEJONG Surgical Gown Soft is FYA.

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: FYA)

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery Studio K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC

Официальный источник

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