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FDA 510(k)

THE NEEDLE NABBER

K-Number: K911597 · 1991-07-26

ApplicantJ. Simmons Instrument , Ltd.
Decision Date1991-07-26
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE NEEDLE NABBER is the device name listed in this FDA 510(k) record. The listed applicant is J. Simmons Instrument , Ltd.. It received FDA 510(k) clearance on 1991-07-26 under 510(k) number K911597. 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 THE NEEDLE NABBER?

THE NEEDLE NABBER is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is J. Simmons Instrument , Ltd.. The 510(k) number is K911597.

When did THE NEEDLE NABBER receive FDA 510(k) clearance?

THE NEEDLE NABBER received FDA 510(k) clearance on 1991-07-26, under 510(k) number K911597.

Who is the listed applicant for THE NEEDLE NABBER?

The FDA 510(k) record lists J. Simmons Instrument , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE NEEDLE NABBER?

The FDA product code for THE NEEDLE NABBER 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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