Device Classification Name |
Block, Bite
|
510(k) Number |
K201309 |
Device Name |
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium |
Applicant |
MECTA Corporation |
19799 SW 95th Avenue |
Suite B |
Tualatin,
OR
97062
|
|
Applicant Contact |
Adrian Kettering |
Correspondent |
MECTA Corporation |
19799 SW 95th Avenue |
Suite B |
Tualatin,
OR
97062
|
|
Correspondent Contact |
Adrian Kettering |
Regulation Number | 882.5070
|
Classification Product Code |
|
Date Received | 05/15/2020 |
Decision Date | 06/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|