FDA 510(k)

Disposable Surgical Gown, Disposable Reinforced Surgical Gown

Numéro K : K212869 · 2021-12-13

DemandeurFugou County Shenxiang Manufacturing Co., Ltd.

Date de décision2021-12-13

Code produitFYA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Surgical Gown, Disposable Reinforced Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Fugou County Shenxiang Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K212869. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

Disposable Surgical Gown, Disposable Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Fugou County Shenxiang Manufacturing Co., Ltd.. The 510(k) number is K212869.

When did Disposable Surgical Gown, Disposable Reinforced Surgical Gown receive FDA 510(k) clearance?

Disposable Surgical Gown, Disposable Reinforced Surgical Gown received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212869.

Who is the listed applicant for Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

The FDA 510(k) record lists Fugou County Shenxiang Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

The FDA product code for Disposable Surgical Gown, Disposable Reinforced Surgical Gown is FYA.

Essais cliniques associés

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Dispositifs connexes (Code : FYA)

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Source officielle

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