K885233 is an FDA 510(k) clearance for the NOVA DIAMOND. This device is classified as a Instrument, Diamond, Dental (Class I - General Controls, product code DZP).
Submitted by Microcopy, Div. Neo-Flo, Inc. (Kennesaw, US). The FDA issued a Cleared decision on February 13, 1989, 55 days after receiving the submission on December 20, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4535.
| 510(k) Number | K885233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1988 |
| Decision Date | February 13, 1989 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DZP — Instrument, Diamond, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4535 |