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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K190617
Device Name Wrap accessory electrodes
Applicant
Hi-Dow International, Inc.
2555 Metro Blvd.
Maryland Heights,  MO  63043
Applicant Contact Eric Chen
Correspondent
Hi-Dow International, Inc.
2555 Metro Blvd.
Maryland Heights,  MO  63043
Correspondent Contact Eric Chen
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/11/2019
Decision Date 07/02/2019
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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