HOLLOW FIBER DIALYZER FOCUS 70H— 510(k) K893677
Substantially EquivalentNational Medical Care, Medical Products Div., Inc.
FDA 510(k) clearance K893677 for HOLLOW FIBER DIALYZER FOCUS 70H, Substantially Equivalent on 1989-07-24. 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.