K803068 is an FDA 510(k) clearance for the NIKKISO ND-14 PARALLEL FLOW DIALYZER. This device is classified as a Dialyzer, Parallel Flow (Class II - Special Controls, product code FJG).
Submitted by NIKKISO CO., LTD. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981, 90 days after receiving the submission on December 4, 1980.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K803068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1980 |
| Decision Date | March 04, 1981 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FJG — Dialyzer, Parallel Flow |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |