K914790 is an FDA 510(k) clearance for the HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R. This device is classified as a Dialyzer, Capillary, Hollow Fiber (Class II - Special Controls, product code FJI).
Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on March 5, 1993, 499 days after receiving the submission on October 23, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K914790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1991 |
| Decision Date | March 05, 1993 |
| Days to Decision | 499 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FJI — Dialyzer, Capillary, Hollow Fiber |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |