FDA 510(k)

STERILE DISPOSABLE NEEDLES

K-Number: K832102 · 1983-09-01

Decision Date1983-09-01

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Lee Medical Intl., Inc.. It received FDA 510(k) clearance on 1983-09-01 under 510(k) number K832102. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE DISPOSABLE NEEDLES?

STERILE DISPOSABLE NEEDLES is a medical device that received FDA 510(k) clearance on 1983-09-01. The listed applicant is Lee Medical Intl., Inc.. The 510(k) number is K832102.

When did STERILE DISPOSABLE NEEDLES receive FDA 510(k) clearance?

STERILE DISPOSABLE NEEDLES received FDA 510(k) clearance on 1983-09-01, under 510(k) number K832102.

Who is the listed applicant for STERILE DISPOSABLE NEEDLES?

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

What is the FDA product code for STERILE DISPOSABLE NEEDLES?

The FDA product code for STERILE DISPOSABLE NEEDLES is FMI.

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Other records listing Lee Medical Intl., Inc. as applicant

K840082STERILE INSULIN DISPOS. NEEDLE/SYRINGE K840081IV ADMINISTRATION SET K840083STERILE INSULIN DISPOS. NEEDLE/GREEN K832104STERILE DISP. BUTTERFLY INFUSION SET K832105ADMINISTRATIVE IV SET K832101STERILE DISPOSABLE SYRINGE

View all 8 devices →

Related Devices (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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.