K952343 is an FDA 510(k) clearance for the FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER. 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 December 22, 1995, 217 days after receiving the submission on May 19, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K952343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1995 |
| Decision Date | December 22, 1995 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJI — Dialyzer, Capillary, Hollow Fiber |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |