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FDA 510(k)

JAMBRO Single Core A Sterilization wrap

N.º K: K182656 · 2019-06-11

SolicitanteJiangsu Zhande Medical Supplies Co., Ltd.
Fecha de decisión2019-06-11
Código de productoFRG
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

JAMBRO Single Core A Sterilization wrap is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Zhande Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2019-06-11 under 510(k) number K182656. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the JAMBRO Single Core A Sterilization wrap?

JAMBRO Single Core A Sterilization wrap is a medical device that received FDA 510(k) clearance on 2019-06-11. The listed applicant is Jiangsu Zhande Medical Supplies Co., Ltd.. The 510(k) number is K182656.

When did JAMBRO Single Core A Sterilization wrap receive FDA 510(k) clearance?

JAMBRO Single Core A Sterilization wrap received FDA 510(k) clearance on 2019-06-11, under 510(k) number K182656.

Who is the listed applicant for JAMBRO Single Core A Sterilization wrap?

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

What is the FDA product code for JAMBRO Single Core A Sterilization wrap?

The FDA product code for JAMBRO Single Core A Sterilization wrap is FRG.

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Dispositivos relacionados (Código: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Fuente oficial

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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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