Submission Details
| 510(k) Number | K884813 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 1988 |
| Decision Date | January 05, 1989 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
K884813 is an FDA 510(k) clearance for the MODEL 200A ELECTRONIC FORCE-SENSING PROBE, a Gauge, Depth, Instrument, Dental (Class I — General Controls, product code EIL), submitted by Vine Valley Research (Middlesex, US). The FDA issued a Cleared decision on January 5, 1989, 49 days after receiving the submission on November 17, 1988. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K884813 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 1988 |
| Decision Date | January 05, 1989 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIL — Gauge, Depth, Instrument, Dental |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4565 |