K822658 is an FDA 510(k) clearance for the EXTENSION SET TYPE DP. This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 21, 1982, 48 days after receiving the submission on September 3, 1982.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K822658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1982 |
| Decision Date | October 21, 1982 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKX — System, Peritoneal, Automatic Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |