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FDA 510(k)

HESUNG DISPOSABLE SYRINGE

K-Number: K841566 · 1984-07-17

ApplicantAmkor Trading Co.
Decision Date1984-07-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HESUNG DISPOSABLE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Amkor Trading Co.. It received FDA 510(k) clearance on 1984-07-17 under 510(k) number K841566. 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 HESUNG DISPOSABLE SYRINGE?

HESUNG DISPOSABLE SYRINGE is a medical device that received FDA 510(k) clearance on 1984-07-17. The listed applicant is Amkor Trading Co.. The 510(k) number is K841566.

When did HESUNG DISPOSABLE SYRINGE receive FDA 510(k) clearance?

HESUNG DISPOSABLE SYRINGE received FDA 510(k) clearance on 1984-07-17, under 510(k) number K841566.

Who is the listed applicant for HESUNG DISPOSABLE SYRINGE?

The FDA 510(k) record lists Amkor Trading Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HESUNG DISPOSABLE SYRINGE?

The FDA product code for HESUNG DISPOSABLE SYRINGE is FMF.

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Other records listing Amkor Trading Co. 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.

K841561HESUNG'S BLOOD DONOR SETSK841562HESUNG BLOOD TRANSFUSION SETSK841563HESUNG'S SOLUTION INFUSION SETSK841564HESUNG SCALP VEIN SETK841565HESUNG'S HYPERDERMIC NEEDLES

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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