FDA 510(k)

Sol-M Insulin Syringe, Sol-M TB Syringe

N.º K: K153537 · 2016-06-17

Fecha de decisión2016-06-17

Código de productoFMF

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sol-M Insulin Syringe, Sol-M TB Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K153537. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sol-M Insulin Syringe, Sol-M TB Syringe?

Sol-M Insulin Syringe, Sol-M TB Syringe is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K153537.

When did Sol-M Insulin Syringe, Sol-M TB Syringe receive FDA 510(k) clearance?

Sol-M Insulin Syringe, Sol-M TB Syringe received FDA 510(k) clearance on 2016-06-17, under 510(k) number K153537.

Who is the listed applicant for Sol-M Insulin Syringe, Sol-M TB Syringe?

The FDA 510(k) record lists Sol-Millennium Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sol-M Insulin Syringe, Sol-M TB Syringe?

The FDA product code for Sol-M Insulin Syringe, Sol-M TB Syringe is FMF.

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Otros registros que enlistan a Sol-Millennium Medical, Inc. como solicitante

K252184SOL-M Luer Lock Syringe with Exchangeable Needle Tray K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Fuente oficial

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