FDA 510(k)

LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing

Numéro K : K223359 · 2023-12-21

DemandeurHuizhou Foryou Medical Devices Co., Ltd.

Date de décision2023-12-21

Code produitFRO

DécisionSubstantially Equivalent

Résumé du dispositif

LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K223359. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing?

LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K223359.

When did LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing receive FDA 510(k) clearance?

LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing received FDA 510(k) clearance on 2023-12-21, under 510(k) number K223359.

Who is the listed applicant for LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing?

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

What is the FDA product code for LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing?

The FDA product code for LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing is FRO. This falls under the Anesthesiology category.

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Autres dossiers indiquant Huizhou Foryou Medical Devices Co., Ltd. en tant que demandeur

K254256LUOFUCON® Wound Matrix K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)K240809LUOFUCON® Silver Collagen Dressing K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)

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Dispositifs connexes (Code : FRO)

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Source officielle

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