K020947 is an FDA 510(k) clearance for the MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on April 17, 2002, 23 days after receiving the submission on March 25, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K020947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2002 |
| Decision Date | April 17, 2002 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |