K932878 is an FDA 510(k) clearance for the PRECISION INTRA-ORAL SCOPES. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Precise Optics (Gardner, US). The FDA issued a Cleared decision on January 6, 1994, 206 days after receiving the submission on June 14, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K932878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1993 |
| Decision Date | January 06, 1994 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |