HESUNG'S BLOOD DONOR SETS— 510(k) K841561

Name: FDA 510(k) clearance K841561
Creator: U.S. Food and Drug Administration
Published: 1984-08-30

Substantially Equivalent

Amkor Trading Co.

FDA 510(k) clearance K841561 for HESUNG'S BLOOD DONOR SETS, Substantially Equivalent on 1984-08-30. Applicant: Amkor Trading Co.. Device class: 2.

Clearance details

Applicant: Amkor Trading Co.
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1984-07-13
Decision date: 1984-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Amkor Trading Co.

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K841562 — HESUNG BLOOD TRANSFUSION SETS1984-07-23
K841563 — HESUNG'S SOLUTION INFUSION SETS1984-07-17
K841564 — HESUNG SCALP VEIN SET1984-07-17
K841565 — HESUNG'S HYPERDERMIC NEEDLES1984-07-17
K841566 — HESUNG DISPOSABLE SYRINGE1984-07-17

Adverse events under product code BRZ

product code BRZ

Malfunction: 458
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.