TEMP-STIK MODEL #300— 510(k) K791558

Substantially Equivalent

Temp-Stik Corp.

FDA 510(k) clearance K791558 for TEMP-STIK MODEL #300, Substantially Equivalent on 1979-09-12. Applicant: Temp-Stik Corp..

Clearance details

Applicant: Temp-Stik Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1979-08-17
Decision date: 1979-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.