DURA-BOARD ARMBOARD— 510(k) K964273

Substantially Equivalent

Allen Medical Systems, Inc.

FDA 510(k) clearance K964273 for DURA-BOARD ARMBOARD, Substantially Equivalent on 1997-01-08. Applicant: Allen Medical Systems, Inc..

Clearance details

Applicant: Allen Medical Systems, Inc.
Product code: Code GDC
Advisory panel: General, Plastic Surgery
Date received: 1996-10-28
Decision date: 1997-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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Adverse events under product code GDC

product code GDC

Malfunction: 791
Total: 791

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.