INGLAT-O-BALL— 510(k) K904774

Substantially Equivalent

Milex Products, Inc.

FDA 510(k) clearance K904774 for INGLAT-O-BALL, Substantially Equivalent on 1990-12-07. Applicant: Milex Products, Inc..

Clearance details

Applicant: Milex Products, Inc.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 1990-10-22
Decision date: 1990-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HHW

product code HHW

Malfunction: 485
Total: 485

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.