K980658 is an FDA 510(k) clearance for the PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234. This device is classified as a Dialyzer, Capillary, Hollow Fiber (Class II - Special Controls, product code FJI).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on May 19, 1998, 89 days after receiving the submission on February 19, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K980658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1998 |
| Decision Date | May 19, 1998 |
| Days to Decision | 89 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 |