FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER— 510(k) K952343
Substantially EquivalentNational Medical Care, Medical Products Div., Inc.
FDA 510(k) clearance K952343 for FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER, Substantially Equivalent on 1995-12-22. Applicant: National Medical Care, Medical Products Div., Inc..
Clearance details
- Applicant
- National Medical Care, Medical Products Div., Inc.
- Product code
- Code FJI
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockleigh, NJ, US
Adverse events under product code FJI
product code FJI- Death
- 2
- Total
- 2
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.