K790984 is an FDA 510(k) clearance for the KLIP-LITE. This device is classified as a Light, Operating, Dental (Class I - General Controls, product code EAZ).
Submitted by Innovators, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 22, 1979, 150 days after receiving the submission on May 25, 1979.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4630.
| 510(k) Number | K790984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 1979 |
| Decision Date | October 22, 1979 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EAZ — Light, Operating, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4630 |