The following data is part of a premarket notification filed by Mecta Corporation with the FDA for Ect Cotton Bite Block- Size Large, Ect Cotton Bite Block -size Medium.
| Device ID | K201309 |
| 510k Number | K201309 |
| Device Name: | ECT Cotton Bite Block- Size Large, ECT Cotton Bite Block -size Medium |
| Classification | Block, Bite |
| Applicant | MECTA Corporation 19799 SW 95th Avenue Suite B Tualatin, OR 97062 |
| Contact | Adrian Kettering |
| Correspondent | Adrian Kettering MECTA Corporation 19799 SW 95th Avenue Suite B Tualatin, OR 97062 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-15 |
| Decision Date | 2021-06-04 |