GUAMSTAINER— 510(k) K811697

Substantially Equivalent

Tomtec

FDA 510(k) clearance K811697 for GUAMSTAINER, Substantially Equivalent on 1981-07-02. Applicant: Tomtec.

Clearance details

Applicant: Tomtec
Product code: Code KPA
Advisory panel: Pathology
Date received: 1981-06-16
Decision date: 1981-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KPA

product code KPA

Malfunction: 1,177
Total: 1,177

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.