STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP— 510(k) K994321

Substantially Equivalent

Automatic Liquid Packaging, Inc.

FDA 510(k) clearance K994321 for STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP, Substantially Equivalent on 2000-10-25. Applicant: Automatic Liquid Packaging, Inc..

Clearance details

Applicant: Automatic Liquid Packaging, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1999-12-22
Decision date: 2000-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, IL, US

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Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.