MARC MEDICAL PROBE COVER-200— 510(k) K850424

Substantially Equivalent

K&M Plastics

FDA 510(k) clearance K850424 for MARC MEDICAL PROBE COVER-200, Substantially Equivalent on 1985-05-15. Applicant: K&M Plastics.

Clearance details

Applicant: K&M Plastics
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1985-02-04
Decision date: 1985-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.