FDA 510(k)

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use

N.º K: K183665 · 2019-09-06

SolicitanteJiangsu Micsafe Medical Technology Co., Ltd.

Fecha de decisión2019-09-06

Código de productoMEG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K183665. 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 Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use?

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. The 510(k) number is K183665.

When did Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use receive FDA 510(k) clearance?

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use received FDA 510(k) clearance on 2019-09-06, under 510(k) number K183665.

Who is the listed applicant for Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use?

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

What is the FDA product code for Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use?

The FDA product code for Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use is MEG.

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Otros registros que enlistan a Jiangsu Micsafe Medical Technology Co., Ltd. como solicitante

K212019Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single K202570Insulin Syringe, Insulin Syringe with Safety Retractable K202205Surgical Face Mask K181426Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)

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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