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FDA 510(k)

DRAGON HEART PISTON SYRINGE

K-Number: K042547 · 2004-12-01

ApplicantDragon Heart Medical Devices Co., Ltd.
Decision Date2004-12-01
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DRAGON HEART PISTON SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Dragon Heart Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2004-12-01 under 510(k) number K042547. 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 DRAGON HEART PISTON SYRINGE?

DRAGON HEART PISTON SYRINGE is a medical device that received FDA 510(k) clearance on 2004-12-01. The listed applicant is Dragon Heart Medical Devices Co., Ltd.. The 510(k) number is K042547.

When did DRAGON HEART PISTON SYRINGE receive FDA 510(k) clearance?

DRAGON HEART PISTON SYRINGE received FDA 510(k) clearance on 2004-12-01, under 510(k) number K042547.

Who is the listed applicant for DRAGON HEART PISTON SYRINGE?

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

What is the FDA product code for DRAGON HEART PISTON SYRINGE?

The FDA product code for DRAGON HEART PISTON SYRINGE is FMF.

Related Clinical Trials

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Other records listing Dragon Heart Medical Devices Co., Ltd. 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.

K043235DRAGON HEART I.V. SET

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT 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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