STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109— 510(k) K000964
Substantially EquivalentAutomatic Liquid Packaging, Inc.
FDA 510(k) clearance K000964 for STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109, Substantially Equivalent on 2000-04-25. Applicant: Automatic Liquid Packaging, Inc..
Clearance details
- Applicant
- Automatic Liquid Packaging, Inc.
- Product code
- Code JOH
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Woodstock, IL, US
Adverse events under product code JOH
product code JOH- Death
- 42
- Injury
- 1,344
- Malfunction
- 5,608
- Other
- 1
- Total
- 6,995
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.