K944436 is an FDA 510(k) clearance for the COBE CENTRYSYSTEM CS 200 DIALYZER. This device is classified as a Dialyzer, Capillary, Hollow Fiber (Class II - Special Controls, product code FJI).
Submitted by Cobe Renal Care, Inc. (Lakewood, US). The FDA issued a Cleared decision on January 29, 1996, 504 days after receiving the submission on September 12, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K944436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 1994 |
| Decision Date | January 29, 1996 |
| Days to Decision | 504 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 |