FDA 510(k)

Kopac Sterile Needle

N.º K: K172483 · 2018-06-21

Fecha de decisión2018-06-21

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Kopac Sterile Needle is the device name listed in this FDA 510(k) record. The listed applicant is Poonglim Pharmatech, Inc.. It received FDA 510(k) clearance on 2018-06-21 under 510(k) number K172483. 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 Kopac Sterile Needle?

Kopac Sterile Needle is a medical device that received FDA 510(k) clearance on 2018-06-21. The listed applicant is Poonglim Pharmatech, Inc.. The 510(k) number is K172483.

When did Kopac Sterile Needle receive FDA 510(k) clearance?

Kopac Sterile Needle received FDA 510(k) clearance on 2018-06-21, under 510(k) number K172483.

Who is the listed applicant for Kopac Sterile Needle?

The FDA 510(k) record lists Poonglim Pharmatech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kopac Sterile Needle?

The FDA product code for Kopac Sterile Needle is FMI.

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Otros registros que enlistan a Poonglim Pharmatech, Inc. como solicitante

K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe K221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe K210443PLPT LDV (Low Dead Volume) Sterile Syringe K210444EZ-Injec LDV Sterile Safety Needle K192222EZ-Inject Single use 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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