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FDA 510(k)

DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH

K-Number: K861081 · 1986-04-09

ApplicantPerkins & Perkins, Inc.
Decision Date1986-04-09
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Perkins & Perkins, Inc.. It received FDA 510(k) clearance on 1986-04-09 under 510(k) number K861081. 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 DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH?

DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH is a medical device that received FDA 510(k) clearance on 1986-04-09. The listed applicant is Perkins & Perkins, Inc.. The 510(k) number is K861081.

When did DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH receive FDA 510(k) clearance?

DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH received FDA 510(k) clearance on 1986-04-09, under 510(k) number K861081.

Who is the listed applicant for DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH?

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

What is the FDA product code for DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH?

The FDA product code for DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH 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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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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