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FDA 510(k)

Sterile Hypodermic Syringe for Single Use

K-Number: K212207 · 2023-03-23

ApplicantShandong Weigao Group Medical Polymer Co., Ltd.
Decision Date2023-03-23
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Syringe for Single Use is a medical device manufactured by Shandong Weigao Group Medical Polymer Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under approval number K212207. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Hypodermic Syringe for Single Use?

Sterile Hypodermic Syringe for Single Use is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by Shandong Weigao Group Medical Polymer Co., Ltd.. The 510(k) number is K212207.

When was Sterile Hypodermic Syringe for Single Use approved by the FDA?

Sterile Hypodermic Syringe for Single Use received FDA 510(k) clearance on 2023-03-23, under approval number K212207.

What company makes Sterile Hypodermic Syringe for Single Use?

Sterile Hypodermic Syringe for Single Use is manufactured by Shandong Weigao Group Medical Polymer Co., Ltd..

What is the FDA product code for Sterile Hypodermic Syringe for Single Use?

The FDA product code for Sterile Hypodermic Syringe for Single Use is FMF.

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Other Devices by Shandong Weigao Group Medical Polymer Co., Ltd.

K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

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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