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FDA 510(k)

Disposable High Pressure Syringe

K-Number: K170279 · 2017-12-12

ApplicantUnion Medical Shenzhen Co., Ltd.
Decision Date2017-12-12
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable High Pressure Syringe is a medical device manufactured by Union Medical Shenzhen Co., Ltd.. It received FDA 510(k) clearance on 2017-12-12 under approval number K170279. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable High Pressure Syringe?

Disposable High Pressure Syringe is a medical device that received FDA 510(k) clearance on 2017-12-12. It is manufactured by Union Medical Shenzhen Co., Ltd.. The 510(k) number is K170279.

When was Disposable High Pressure Syringe approved by the FDA?

Disposable High Pressure Syringe received FDA 510(k) clearance on 2017-12-12, under approval number K170279.

What company makes Disposable High Pressure Syringe?

Disposable High Pressure Syringe is manufactured by Union Medical Shenzhen Co., Ltd..

What is the FDA product code for Disposable High Pressure Syringe?

The FDA product code for Disposable High Pressure Syringe is DXT.

Related Clinical Trials

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Related Devices (Code: DXT)

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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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