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FDA 510(k)

DEVONS POINT LOK NEEDLE PROTECTION DEVICE

K-Number: K946289 · 1995-07-10

ApplicantDevon Industries, Inc.
Decision Date1995-07-10
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEVONS POINT LOK NEEDLE PROTECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Devon Industries, Inc.. It received FDA 510(k) clearance on 1995-07-10 under 510(k) number K946289. 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 DEVONS POINT LOK NEEDLE PROTECTION DEVICE?

DEVONS POINT LOK NEEDLE PROTECTION DEVICE is a medical device that received FDA 510(k) clearance on 1995-07-10. The listed applicant is Devon Industries, Inc.. The 510(k) number is K946289.

When did DEVONS POINT LOK NEEDLE PROTECTION DEVICE receive FDA 510(k) clearance?

DEVONS POINT LOK NEEDLE PROTECTION DEVICE received FDA 510(k) clearance on 1995-07-10, under 510(k) number K946289.

Who is the listed applicant for DEVONS POINT LOK NEEDLE PROTECTION DEVICE?

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

What is the FDA product code for DEVONS POINT LOK NEEDLE PROTECTION DEVICE?

The FDA product code for DEVONS POINT LOK NEEDLE PROTECTION DEVICE is FMI.

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Other records listing Devon Industries, 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.

K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)K954015ABG POINT LOK NEEDLE PROTECTION DEVICEK943892POINT OF USE SHARPS A GATORK944114PHLEBOTOMY UNIT SHARPS A GATORK945197THE SHARPS COLLECTION AND DISPOSAL SYSTEMK945485ABG NEEDLE PROTECTION

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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