K894490 is an FDA 510(k) clearance for the STERILE ULTRASOUND TRANSMISSION GEL. This device is classified as a Electrode, Gel, Electrosurgical (Class II - Special Controls, product code JOT).
Submitted by Swedish Trade Council USA (Chicago, US). The FDA issued a Cleared decision on October 5, 1989, 79 days after receiving the submission on July 18, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K894490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1989 |
| Decision Date | October 05, 1989 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | JOT — Electrode, Gel, Electrosurgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |