MITTENS— 510(k) K963469

Substantially Equivalent

Deroyal Industries, Inc.

FDA 510(k) clearance K963469 for MITTENS, Substantially Equivalent on 1996-11-14. Applicant: Deroyal Industries, Inc..

Clearance details

Applicant: Deroyal Industries, Inc.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1996-09-03
Decision date: 1996-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, US

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Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.