PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP— 510(k) K880317

Substantially Equivalent

Automatic Liquid Packaging, Inc.

FDA 510(k) clearance K880317 for PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP, Substantially Equivalent on 1988-02-29. Applicant: Automatic Liquid Packaging, Inc..

Clearance details

Applicant: Automatic Liquid Packaging, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1988-01-26
Decision date: 1988-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, IL, US

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Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.