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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Ave.
Suite B
Tualatin,  OR  97062
Applicant Contact Adrian Kettering
Correspondent
Mecta Corporation
19799 SW 95th Ave.
Suite B
Tualatin,  OR  97062
Correspondent Contact Adrian Kettering
Regulation Number882.5070
Classification Product Code
JXL  
Date Received05/15/2020
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
Predetermined Change
Control Plan Authorized		 No
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