K862840 is an FDA 510(k) clearance for the GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N. This device is classified as a Dialyzer, Parallel Flow (Class II - Special Controls, product code FJG).
Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on September 29, 1986, 62 days after receiving the submission on July 29, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K862840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1986 |
| Decision Date | September 29, 1986 |
| Days to Decision | 62 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 |