K864181 is an FDA 510(k) clearance for the SOMATICS MOUTH GUARD (BITE BLOCK). This device is classified as a Block, Bite (Class II - Special Controls, product code JXL).
Submitted by Somatics, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on November 3, 1986, 7 days after receiving the submission on October 27, 1986.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5070.
| 510(k) Number | K864181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1986 |
| Decision Date | November 03, 1986 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | JXL — Block, Bite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5070 |