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FDA 510(k)

NEEDLE INCAPACITATOR (NEEDLE GUARD)

K-Number: K042907 · 2004-12-22

ApplicantPdmp, Inc.
Decision Date2004-12-22
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEEDLE INCAPACITATOR (NEEDLE GUARD) is the device name listed in this FDA 510(k) record. The listed applicant is Pdmp, Inc.. It received FDA 510(k) clearance on 2004-12-22 under 510(k) number K042907. 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 NEEDLE INCAPACITATOR (NEEDLE GUARD)?

NEEDLE INCAPACITATOR (NEEDLE GUARD) is a medical device that received FDA 510(k) clearance on 2004-12-22. The listed applicant is Pdmp, Inc.. The 510(k) number is K042907.

When did NEEDLE INCAPACITATOR (NEEDLE GUARD) receive FDA 510(k) clearance?

NEEDLE INCAPACITATOR (NEEDLE GUARD) received FDA 510(k) clearance on 2004-12-22, under 510(k) number K042907.

Who is the listed applicant for NEEDLE INCAPACITATOR (NEEDLE GUARD)?

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

What is the FDA product code for NEEDLE INCAPACITATOR (NEEDLE GUARD)?

The FDA product code for NEEDLE INCAPACITATOR (NEEDLE GUARD) is FMI.

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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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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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