K920693 is an FDA 510(k) clearance for the DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9. This device is classified as a Dialyzer, Parallel Flow (Class II - Special Controls, product code FJG).
Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on September 21, 1992, 220 days after receiving the submission on February 14, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K920693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1992 |
| Decision Date | September 21, 1992 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FJG — Dialyzer, Parallel Flow |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |