K980092 is an FDA 510(k) clearance for the SMITH & NEPHEW 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 March 9, 1998, 59 days after receiving the submission on January 9, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K980092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | January 09, 1998 |
| Decision Date | March 09, 1998 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |