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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K221724
Device Name Conductive Gel
Applicant
Tone-A-Matic International, Inc.
145 Traders E., Unit 18
Mississauga,  CA L5Z-3L3
Applicant Contact Manuel Chuck
Correspondent
Tone-A-Matic International, Inc.
145 Traders E., Unit 18
Mississauga,  CA L5Z-3L3
Correspondent Contact Manuel Chuck
Regulation Number882.1275
Classification Product Code
GYB  
Date Received06/14/2022
Decision Date 09/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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