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FDA 510(k)

HESUNG'S BLOOD DONOR SETS

K-Number: K841561 · 1984-08-30

ApplicantAmkor Trading Co.
Decision Date1984-08-30
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HESUNG'S BLOOD DONOR SETS 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 1984-08-30 under 510(k) number K841561. The device is classified under product code BRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HESUNG'S BLOOD DONOR SETS?

HESUNG'S BLOOD DONOR SETS is a medical device that received FDA 510(k) clearance on 1984-08-30. The listed applicant is Amkor Trading Co.. The 510(k) number is K841561.

When did HESUNG'S BLOOD DONOR SETS receive FDA 510(k) clearance?

HESUNG'S BLOOD DONOR SETS received FDA 510(k) clearance on 1984-08-30, under 510(k) number K841561.

Who is the listed applicant for HESUNG'S BLOOD DONOR SETS?

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'S BLOOD DONOR SETS?

The FDA product code for HESUNG'S BLOOD DONOR SETS is BRZ.

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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.

K841562HESUNG BLOOD TRANSFUSION SETSK841563HESUNG'S SOLUTION INFUSION SETSK841564HESUNG SCALP VEIN SETK841566HESUNG DISPOSABLE SYRINGEK841565HESUNG'S HYPERDERMIC NEEDLES

Related Devices (Code: BRZ)

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.

K220558Blood Administration SetsBaxter Healthcare CorporationK210335Blood Administration SetBaxter Healthcare CorporationK132905200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTERArteriocyte Medical Systems, Inc.K083349BLOOD TRANSFUSION SETShan Dong Wei Gao Group Medical Polymer ProductsK073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORFenwal, Inc.K041496PENTATRASFU BLOOD TRANSFUSION SETSPentaferte S.P.A

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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