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FDA 510(k)

TRUJECT

K-Number: K945284 · 1994-12-29

ApplicantClive Craig Co.
Decision Date1994-12-29
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRUJECT is the device name listed in this FDA 510(k) record. The listed applicant is Clive Craig Co.. It received FDA 510(k) clearance on 1994-12-29 under 510(k) number K945284. 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 TRUJECT?

TRUJECT is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Clive Craig Co.. The 510(k) number is K945284.

When did TRUJECT receive FDA 510(k) clearance?

TRUJECT received FDA 510(k) clearance on 1994-12-29, under 510(k) number K945284.

Who is the listed applicant for TRUJECT?

The FDA 510(k) record lists Clive Craig Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUJECT?

The FDA product code for TRUJECT is FMI.

Related Clinical Trials

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Other records listing Clive Craig Co. 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.

K894437PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH

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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