MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE— 510(k) K925572

Substantially Equivalent

Neward Enterprises, Inc.

FDA 510(k) clearance K925572 for MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE, Substantially Equivalent on 1993-10-08. Applicant: Neward Enterprises, Inc..

Clearance details

Applicant: Neward Enterprises, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1992-11-03
Decision date: 1993-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cucamonga, CA, US

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Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.