FDA 510(k)

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask

N.º K: K191355 · 2019-09-11

Fecha de decisión2019-09-11

Código de productoFXX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2019-09-11 under 510(k) number K191355. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask?

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask is a medical device that received FDA 510(k) clearance on 2019-09-11. The listed applicant is 3M Healthcare. The 510(k) number is K191355.

When did 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask receive FDA 510(k) clearance?

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask received FDA 510(k) clearance on 2019-09-11, under 510(k) number K191355.

Who is the listed applicant for 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask?

The FDA product code for 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask is FXX.

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Otros registros que enlistan a 3M Healthcare como solicitante

K1931103M Attest Vaporizado Hidróxido de Peróxido Tri-Métrico Indicador Químico 1348/1348E K1808743M Mascarilla Quirúrgica de Alto Rendimiento, 3M Mascarilla Quirúrgica de Alto Rendimiento con Escudo Facial K1804043M Clarity Ultra Brackets Auto-Ligantes y Sistema de Dispositivo con Recubrimiento Adhesivo K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S K153571Cavilon Advanced High Endurance Skin Protectant

Dispositivos relacionados (Código: FXX)

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

Fuente oficial

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