K950239 is an FDA 510(k) clearance for the SENSIMATIC 500SE. This device is classified as a Unit, Electrosurgical, And Accessories, Dental (Class II - Special Controls, product code EKZ).
Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on June 6, 1995, 137 days after receiving the submission on January 20, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4920.
| 510(k) Number | K950239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 1995 |
| Decision Date | June 06, 1995 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EKZ — Unit, Electrosurgical, And Accessories, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4920 |