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FDA 510(k)

INTRAVENOUS NEEDLE

K-Number: K832904 · 1984-03-30

ApplicantYolan R. Guttman
Decision Date1984-03-30
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTRAVENOUS NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Yolan R. Guttman. It received FDA 510(k) clearance on 1984-03-30 under 510(k) number K832904. 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 INTRAVENOUS NEEDLE?

INTRAVENOUS NEEDLE is a medical device that received FDA 510(k) clearance on 1984-03-30. The listed applicant is Yolan R. Guttman. The 510(k) number is K832904.

When did INTRAVENOUS NEEDLE receive FDA 510(k) clearance?

INTRAVENOUS NEEDLE received FDA 510(k) clearance on 1984-03-30, under 510(k) number K832904.

Who is the listed applicant for INTRAVENOUS NEEDLE?

The FDA 510(k) record lists Yolan R. Guttman as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRAVENOUS NEEDLE?

The FDA product code for INTRAVENOUS NEEDLE is FMI.

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Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed 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.

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