HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE— 510(k) K974758
Substantially EquivalentHydrox Laboratories
FDA 510(k) clearance K974758 for HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elgin, IL, US
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, through . 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.