SANKEN MAT— 510(k) K924005

Substantially Equivalent

Shima American Corp.

FDA 510(k) clearance K924005 for SANKEN MAT, Substantially Equivalent on 1993-06-17. Applicant: Shima American Corp..

Clearance details

Applicant: Shima American Corp.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1992-08-10
Decision date: 1993-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.