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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 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 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
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