K952342 is an FDA 510(k) clearance for the GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS. This device is classified as a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II - Special Controls, product code KDI).
Submitted by Cobe Renal Care, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 15, 1995, 119 days after receiving the submission on May 19, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K952342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1995 |
| Decision Date | September 15, 1995 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |