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FDA 510(k)

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE

K-Number: K970370 · 1997-04-10

ApplicantTsk Laboratory, Japan
Decision Date1997-04-10
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Tsk Laboratory, Japan. It received FDA 510(k) clearance on 1997-04-10 under 510(k) number K970370. 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 TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE?

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE is a medical device that received FDA 510(k) clearance on 1997-04-10. The listed applicant is Tsk Laboratory, Japan. The 510(k) number is K970370.

When did TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE receive FDA 510(k) clearance?

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE received FDA 510(k) clearance on 1997-04-10, under 510(k) number K970370.

Who is the listed applicant for TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE?

The FDA 510(k) record lists Tsk Laboratory, Japan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE?

The FDA product code for TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE is FMI.

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Other records listing Tsk Laboratory, Japan 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.

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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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