K921946 is an FDA 510(k) clearance for the TUM-E-VAC BITE BLOCK. This device is classified as a Block, Bite (Class II - Special Controls, product code JXL).
Submitted by Ethox Corp. (Buffalo, US). The FDA issued a Cleared decision on December 9, 1992, 226 days after receiving the submission on April 27, 1992.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5070.
| 510(k) Number | K921946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1992 |
| Decision Date | December 09, 1992 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | JXL — Block, Bite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5070 |