FDA 510(k)

Sterile Hypodermic Safety Syringes for Single Use

N.º K: K163162 · 2017-03-20

SolicitanteJiangxi Hongda Medical Equipment Group , Ltd.

Fecha de decisión2017-03-20

Código de productoMEG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Hypodermic Safety Syringes for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K163162. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sterile Hypodermic Safety Syringes for Single Use?

Sterile Hypodermic Safety Syringes for Single Use is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K163162.

When did Sterile Hypodermic Safety Syringes for Single Use receive FDA 510(k) clearance?

Sterile Hypodermic Safety Syringes for Single Use received FDA 510(k) clearance on 2017-03-20, under 510(k) number K163162.

Who is the listed applicant for Sterile Hypodermic Safety Syringes for Single Use?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Hypodermic Safety Syringes for Single Use?

The FDA product code for Sterile Hypodermic Safety Syringes for Single Use is MEG.

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Otros registros que enlistan a Jiangxi Hongda Medical Equipment Group , Ltd. como solicitante

K211753Sterile Syringe With Safety Needle K210578Medical Nitrile Examination Gloves (Power free, Blue)K210821Medical PVC Examination Gloves K163160Sterile Single-use Infusion Set K163161Sterile Single-use Syringe with Needle

Dispositivos relacionados (Código: MEG)

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med Corporation K231907Medline Safety Insulin and TB SyringesMedline Industries, LP K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

Fuente oficial

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