FDA 510(k)

HYPODERMIC NEEDLES, SINGLE LUMEN

K-Number: K874414 · 1988-01-14

Decision Date1988-01-14

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HYPODERMIC NEEDLES, SINGLE LUMEN is the device name listed in this FDA 510(k) record. The listed applicant is Harbor Medical Devices, Inc.. It received FDA 510(k) clearance on 1988-01-14 under 510(k) number K874414. 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 HYPODERMIC NEEDLES, SINGLE LUMEN?

HYPODERMIC NEEDLES, SINGLE LUMEN is a medical device that received FDA 510(k) clearance on 1988-01-14. The listed applicant is Harbor Medical Devices, Inc.. The 510(k) number is K874414.

When did HYPODERMIC NEEDLES, SINGLE LUMEN receive FDA 510(k) clearance?

HYPODERMIC NEEDLES, SINGLE LUMEN received FDA 510(k) clearance on 1988-01-14, under 510(k) number K874414.

Who is the listed applicant for HYPODERMIC NEEDLES, SINGLE LUMEN?

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

What is the FDA product code for HYPODERMIC NEEDLES, SINGLE LUMEN?

The FDA product code for HYPODERMIC NEEDLES, SINGLE LUMEN is FMI.

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Other records listing Harbor Medical Devices, Inc. as applicant

K884628HARBORIN CENTRAL VENOUS CATHETER K890518SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM K882657HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT K881884HARBOR CENTRAL VENOUS CATHETER K882190S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM K880297SEA - PORT INFUSION SET

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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.