K902203 is an FDA 510(k) clearance for the TENCKHOFF PERITONEAL DIALYSIS KIT. This device is classified as a Dialyzer, Parallel Flow (Class II - Special Controls, product code FJG).
Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on August 1, 1990, 77 days after receiving the submission on May 16, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K902203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | May 16, 1990 |
| Decision Date | August 01, 1990 |
| Days to Decision | 77 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 |