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FDA 510(k)

AMERSHAM HEALTH NEEDLE-GUARD

K-Number: K033409 · 2004-01-21

ApplicantGettig Pharmaceutical Instrument Co.
Decision Date2004-01-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMERSHAM HEALTH NEEDLE-GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Gettig Pharmaceutical Instrument Co.. It received FDA 510(k) clearance on 2004-01-21 under 510(k) number K033409. 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 AMERSHAM HEALTH NEEDLE-GUARD?

AMERSHAM HEALTH NEEDLE-GUARD is a medical device that received FDA 510(k) clearance on 2004-01-21. The listed applicant is Gettig Pharmaceutical Instrument Co.. The 510(k) number is K033409.

When did AMERSHAM HEALTH NEEDLE-GUARD receive FDA 510(k) clearance?

AMERSHAM HEALTH NEEDLE-GUARD received FDA 510(k) clearance on 2004-01-21, under 510(k) number K033409.

Who is the listed applicant for AMERSHAM HEALTH NEEDLE-GUARD?

The FDA 510(k) record lists Gettig Pharmaceutical Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERSHAM HEALTH NEEDLE-GUARD?

The FDA product code for AMERSHAM HEALTH NEEDLE-GUARD 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 Gettig Pharmaceutical Instrument Co. 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.

K041232GETTIG UNIVERSAL VIAL ACCESS PINK022495GETTIG DISPOSABLE SYRINGESK000455GETTIG GUARDK972285GETTIG STYRL-JECT DELIVERY SYSTEM

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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