DIAL MEDICAL KIT— 510(k) K941543

Unknown

Regulatory & Marketing Services, Inc.

FDA 510(k) clearance K941543 for DIAL MEDICAL KIT, Unknown on 1995-02-16. Applicant: Regulatory & Marketing Services, Inc..

Clearance details

Applicant: Regulatory & Marketing Services, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1994-03-30
Decision date: 1995-02-16
Decision: Unknown
Clearance type: Traditional
Location: Palm Harbor, FL, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.