NON-ADHER PADS— 510(k) K813421

Substantially Equivalent

Abco Dealers, Inc.

FDA 510(k) clearance K813421 for NON-ADHER PADS, Substantially Equivalent on 1981-12-18. Applicant: Abco Dealers, Inc..

Clearance details

Applicant: Abco Dealers, Inc.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1981-12-07
Decision date: 1981-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.