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FDA 510(k)

HESUNG SCALP VEIN SET

K-Number: K841564 · 1984-07-17

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

Device Summary

HESUNG SCALP VEIN SET 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 K841564. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HESUNG SCALP VEIN SET?

HESUNG SCALP VEIN SET 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 K841564.

When did HESUNG SCALP VEIN SET receive FDA 510(k) clearance?

HESUNG SCALP VEIN SET received FDA 510(k) clearance on 1984-07-17, under 510(k) number K841564.

Who is the listed applicant for HESUNG SCALP VEIN SET?

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 SCALP VEIN SET?

The FDA product code for HESUNG SCALP VEIN SET is FPA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SETSK841566HESUNG DISPOSABLE SYRINGEK841565HESUNG'S HYPERDERMIC NEEDLES

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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