FDA 510(k)

DOUBLE ENDED FILTERED TRANSFER NEEDLE

K-Number: K801107 · 1980-05-30

Decision Date1980-05-30

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DOUBLE ENDED FILTERED TRANSFER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical Products, Inc.. It received FDA 510(k) clearance on 1980-05-30 under 510(k) number K801107. 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 DOUBLE ENDED FILTERED TRANSFER NEEDLE?

DOUBLE ENDED FILTERED TRANSFER NEEDLE is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Burron Medical Products, Inc.. The 510(k) number is K801107.

When did DOUBLE ENDED FILTERED TRANSFER NEEDLE receive FDA 510(k) clearance?

DOUBLE ENDED FILTERED TRANSFER NEEDLE received FDA 510(k) clearance on 1980-05-30, under 510(k) number K801107.

Who is the listed applicant for DOUBLE ENDED FILTERED TRANSFER NEEDLE?

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

What is the FDA product code for DOUBLE ENDED FILTERED TRANSFER NEEDLE?

The FDA product code for DOUBLE ENDED FILTERED TRANSFER NEEDLE is FMI.

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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.