FDA 510(k)

Sterile Aesthetic Cannula and Hypodermic Needle

Numéro K : K223327 · 2023-02-16

DemandeurShanghai Kindly Enterprise Development Group Co., Ltd.

Date de décision2023-02-16

Code produitFMI

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Sterile Aesthetic Cannula and Hypodermic Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Kindly Enterprise Development Group Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K223327. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sterile Aesthetic Cannula and Hypodermic Needle?

Sterile Aesthetic Cannula and Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Shanghai Kindly Enterprise Development Group Co., Ltd.. The 510(k) number is K223327.

When did Sterile Aesthetic Cannula and Hypodermic Needle receive FDA 510(k) clearance?

Sterile Aesthetic Cannula and Hypodermic Needle received FDA 510(k) clearance on 2023-02-16, under 510(k) number K223327.

Who is the listed applicant for Sterile Aesthetic Cannula and Hypodermic Needle?

The FDA 510(k) record lists Shanghai Kindly Enterprise Development Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Aesthetic Cannula and Hypodermic Needle?

The FDA product code for Sterile Aesthetic Cannula and Hypodermic Needle is FMI.

Essais cliniques associés

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Autres dossiers indiquant Shanghai Kindly Enterprise Development Group Co., Ltd. en tant que demandeur

K223678Sterile Syringes for Single Use

Dispositifs connexes (Code : 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.

Source officielle

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