THE EQUALIZER— 510(k) K801328

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K801328 for THE EQUALIZER, Substantially Equivalent on 1980-06-09. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code MDM
Advisory panel: General, Plastic Surgery
Date received: 1980-06-03
Decision date: 1980-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.