3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP— 510(k) K980829

Substantially Equivalent

Steripak, Ltd.

FDA 510(k) clearance K980829 for 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP, Substantially Equivalent on 1998-06-02. Applicant: Steripak, Ltd..

Clearance details

Applicant: Steripak, Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1998-03-04
Decision date: 1998-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northvale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.