ULE-2, MULE-2, HAND ACCESSORY KIT— 510(k) K962855

Substantially Equivalent

Penny and Giles Biometrics , Ltd.

FDA 510(k) clearance K962855 for ULE-2, MULE-2, HAND ACCESSORY KIT, Substantially Equivalent on 1996-12-11. Applicant: Penny and Giles Biometrics , Ltd..

Clearance details

Applicant: Penny and Giles Biometrics , Ltd.
Product code: Code ISD
Advisory panel: Physical Medicine
Date received: 1996-07-22
Decision date: 1996-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwent, Wales, GB

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Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

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.