MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE— 510(k) K001616
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K001616 for MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE, Substantially Equivalent on 2000-07-27. Applicant: Abbott Laboratories.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code FOZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Abbott Park, IL, US
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.