PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)— 510(k) K954331
Substantially EquivalentPall Biomedical Products Co.
FDA 510(k) clearance K954331 for PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER), Substantially Equivalent on 1997-01-09. Applicant: Pall Biomedical Products Co..
Clearance details
- Applicant
- Pall Biomedical Products Co.
- Product code
- Code FPB
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Hills, NY, US
Adverse events under product code FPB
product code FPB- Other
- 1
- Total
- 1
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.