FDA 510(k)

LUOFUCON Silicone Ag Foam Dressing with Border

Número K: K170077 · 2017-03-30

RequerenteHuizhou Foryou Medical Devices Co., Ltd.

Data da decisão2017-03-30

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

LUOFUCON Silicone Ag Foam Dressing with Border 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 2017-03-30 under 510(k) number K170077. 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.

Perguntas frequentes

What is the LUOFUCON Silicone Ag Foam Dressing with Border?

LUOFUCON Silicone Ag Foam Dressing with Border is a medical device that received FDA 510(k) clearance on 2017-03-30. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K170077.

When did LUOFUCON Silicone Ag Foam Dressing with Border receive FDA 510(k) clearance?

LUOFUCON Silicone Ag Foam Dressing with Border received FDA 510(k) clearance on 2017-03-30, under 510(k) number K170077.

Who is the listed applicant for LUOFUCON Silicone Ag Foam Dressing with Border?

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 Silicone Ag Foam Dressing with Border?

The FDA product code for LUOFUCON Silicone Ag Foam Dressing with Border is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Huizhou Foryou Medical Devices Co., Ltd. como candidato(a)

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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Fonte oficial

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