K935390 is an FDA 510(k) clearance for the SIROLUX FANTASTIC. This device is classified as a Light, Operating, Dental (Class I - General Controls, product code EAZ).
Submitted by Pelton & Crane Co. (Charlotte, US). The FDA issued a Cleared decision on December 10, 1993, 32 days after receiving the submission on November 8, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4630.
| 510(k) Number | K935390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1993 |
| Decision Date | December 10, 1993 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EAZ — Light, Operating, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4630 |