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FDA 510(k)

STAT MEDICAL PEN NEEDLE

K-Number: K042917 · 2005-04-22

ApplicantEmergogroup, Inc.
Decision Date2005-04-22
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STAT MEDICAL PEN NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Emergogroup, Inc.. It received FDA 510(k) clearance on 2005-04-22 under 510(k) number K042917. 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 STAT MEDICAL PEN NEEDLE?

STAT MEDICAL PEN NEEDLE is a medical device that received FDA 510(k) clearance on 2005-04-22. The listed applicant is Emergogroup, Inc.. The 510(k) number is K042917.

When did STAT MEDICAL PEN NEEDLE receive FDA 510(k) clearance?

STAT MEDICAL PEN NEEDLE received FDA 510(k) clearance on 2005-04-22, under 510(k) number K042917.

Who is the listed applicant for STAT MEDICAL PEN NEEDLE?

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

What is the FDA product code for STAT MEDICAL PEN NEEDLE?

The FDA product code for STAT MEDICAL PEN NEEDLE is FMI.

Related Clinical Trials

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.

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Other records listing Emergogroup, Inc. as applicant

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.

K032091SMART KLAMP VARIOUS BY SIZE

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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