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FDA 510(k)

HYPODERMIC NEEDLES

K-Number: K841577 · 1984-05-07

ApplicantAva Medical Products of Canada, Inc.
Decision Date1984-05-07
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYPODERMIC NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Ava Medical Products of Canada, Inc.. It received FDA 510(k) clearance on 1984-05-07 under 510(k) number K841577. 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 HYPODERMIC NEEDLES?

HYPODERMIC NEEDLES is a medical device that received FDA 510(k) clearance on 1984-05-07. The listed applicant is Ava Medical Products of Canada, Inc.. The 510(k) number is K841577.

When did HYPODERMIC NEEDLES receive FDA 510(k) clearance?

HYPODERMIC NEEDLES received FDA 510(k) clearance on 1984-05-07, under 510(k) number K841577.

Who is the listed applicant for HYPODERMIC NEEDLES?

The FDA 510(k) record lists Ava Medical Products of Canada, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPODERMIC NEEDLES?

The FDA product code for HYPODERMIC NEEDLES 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 Ava Medical Products of Canada, 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.

K841578DISPOSABLE SYRINGE

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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