FDA 510(k)

TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)

K-Number: K031062 · 2003-05-02

ApplicantTaiject Medical Device Co., Ltd.

Decision Date2003-05-02

Product CodeMEG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) is the device name listed in this FDA 510(k) record. The listed applicant is Taiject Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2003-05-02 under 510(k) number K031062. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)?

TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) is a medical device that received FDA 510(k) clearance on 2003-05-02. The listed applicant is Taiject Medical Device Co., Ltd.. The 510(k) number is K031062.

When did TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) receive FDA 510(k) clearance?

TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) received FDA 510(k) clearance on 2003-05-02, under 510(k) number K031062.

Who is the listed applicant for TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)?

The FDA 510(k) record lists Taiject Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)?

The FDA product code for TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) is MEG.

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Other records listing Taiject Medical Device Co., Ltd. as applicant

K042426TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)K023458TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)K022278TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)

Related Devices (Code: MEG)

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med Corporation K231907Medline Safety Insulin and TB SyringesMedline Industries, LP K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

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.