THE AIRCEL SYSTEM— 510(k) K954593

Substantially Equivalent

Marcon Group, Inc.

FDA 510(k) clearance K954593 for THE AIRCEL SYSTEM, Substantially Equivalent on 1996-02-06. Applicant: Marcon Group, Inc..

Clearance details

Applicant: Marcon Group, Inc.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1995-10-03
Decision date: 1996-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.