KUNG SHIN, HMEF SK203— 510(k) K032878

Substantially Equivalent

Kung Shin Plastics Co., Ltd.

FDA 510(k) clearance K032878 for KUNG SHIN, HMEF SK203, Substantially Equivalent on 2004-09-20. Applicant: Kung Shin Plastics Co., Ltd..

Clearance details

Applicant: Kung Shin Plastics Co., Ltd.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2003-09-15
Decision date: 2004-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

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Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.