K991908 is an FDA 510(k) clearance for the IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Idemsa (Westbury, US). The FDA issued a Cleared decision on April 17, 2000, 315 days after receiving the submission on June 7, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K991908 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 07, 1999 |
| Decision Date | April 17, 2000 |
| Days to Decision | 315 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 |