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FDA 510(k)

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)

N.º K: K153409 · 2016-11-15

SolicitanteProtect U Guard, LLC
Fecha de decisión2016-11-15
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is the device name listed in this FDA 510(k) record. The listed applicant is Protect U Guard, LLC. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K153409. 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 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)?

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Protect U Guard, LLC. The 510(k) number is K153409.

When did Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) receive FDA 510(k) clearance?

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) received FDA 510(k) clearance on 2016-11-15, under 510(k) number K153409.

Who is the listed applicant for Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)?

The FDA 510(k) record lists Protect U Guard, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)?

The FDA product code for Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is FXX.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: FXX)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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