K863767 is an FDA 510(k) clearance for the GLASS MOUTH MIRRORS, REUSABLE. This device is classified as a Mirror, Mouth (Class I - General Controls, product code EAX).
Submitted by The Medical Group, Inc. (Reno, US). The FDA issued a Cleared decision on October 30, 1986, 35 days after receiving the submission on September 25, 1986.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K863767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1986 |
| Decision Date | October 30, 1986 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EAX — Mirror, Mouth |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |