HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE— 510(k) K974759

Substantially Equivalent

Hydrox Laboratories

FDA 510(k) clearance K974759 for HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE, Substantially Equivalent on 1998-03-09. Applicant: Hydrox Laboratories.

Clearance details

Applicant: Hydrox Laboratories
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1997-12-19
Decision date: 1998-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elgin, 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.