AUTO TURNER— 510(k) K850419

Substantially Equivalent

George J. Kamilar

FDA 510(k) clearance K850419 for AUTO TURNER, Substantially Equivalent on 1985-05-21. Applicant: George J. Kamilar.

Clearance details

Applicant: George J. Kamilar
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1985-02-04
Decision date: 1985-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brightwaters, NY, 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.