K201309 is an FDA 510(k) clearance for the ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium. This device is classified as a Block, Bite (Class II - Special Controls, product code JXL).
Submitted by Mecta Corporation (Tualatin, US). The FDA issued a Cleared decision on June 4, 2021, 385 days after receiving the submission on May 15, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5070.
| 510(k) Number | K201309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2020 |
| Decision Date | June 04, 2021 |
| Days to Decision | 385 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXL — Block, Bite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5070 |