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FDA 510(k)

BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID

K-Number: K002213 · 2000-10-03

ApplicantHunter Research Laboratories, Inc.
Decision Date2000-10-03
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID is the device name listed in this FDA 510(k) record. The listed applicant is Hunter Research Laboratories, Inc.. It received FDA 510(k) clearance on 2000-10-03 under 510(k) number K002213. 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 BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID?

BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID is a medical device that received FDA 510(k) clearance on 2000-10-03. The listed applicant is Hunter Research Laboratories, Inc.. The 510(k) number is K002213.

When did BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID receive FDA 510(k) clearance?

BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID received FDA 510(k) clearance on 2000-10-03, under 510(k) number K002213.

Who is the listed applicant for BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID?

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

What is the FDA product code for BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID?

The FDA product code for BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID is FMI.

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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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