FDA 510(k)

DROPLET PEN NEEDLE

N.º K: K171982 · 2018-03-21

Fecha de decisión2018-03-21

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

DROPLET PEN NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Htl-Strefa S.A. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K171982. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DROPLET PEN NEEDLE?

DROPLET PEN NEEDLE is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Htl-Strefa S.A. The 510(k) number is K171982.

When did DROPLET PEN NEEDLE receive FDA 510(k) clearance?

DROPLET PEN NEEDLE received FDA 510(k) clearance on 2018-03-21, under 510(k) number K171982.

Who is the listed applicant for DROPLET PEN NEEDLE?

The FDA 510(k) record lists Htl-Strefa S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DROPLET PEN NEEDLE?

The FDA product code for DROPLET PEN NEEDLE is FMI.

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Otros registros que enlistan a Htl-Strefa S.A como solicitante

K250016droplet® personal lancets K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets K202340Droplet Pen Needle 30G & 33G K192082Droplet Pen Needle 34G K170988DropSafe Safety Pen Needle

Dispositivos relacionados (Código: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Fuente oficial

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