FDA 510(k)

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12

N.º K: K160271 · 2016-07-15

Fecha de decisión2016-07-15

Código de productoMSH

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 is the device name listed in this FDA 510(k) record. The listed applicant is San-M Package Co., Ltd.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K160271. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12?

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is San-M Package Co., Ltd.. The 510(k) number is K160271.

When did N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 receive FDA 510(k) clearance?

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 received FDA 510(k) clearance on 2016-07-15, under 510(k) number K160271.

Who is the listed applicant for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12?

The FDA 510(k) record lists San-M Package Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12?

The FDA product code for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 is MSH.

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Otros registros que enlistan a San-M Package Co., Ltd. como solicitante

K221534Surgical Face Masks (Ear Loops And Tie-On)K160269Surgical Face Masks (Ear loops and Tie-on)

Dispositivos relacionados (Código: MSH)

K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and SmallOwens & Minor (O&M) Halyard, Inc.K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd.K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S3M Healthcare

Fuente oficial

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