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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 K172703
Device Name Disposable Snap Electrode
Applicant
Embla Systems
1 Hines Rd.
Suite 202
Kanata,  CA K2K 3C7
Applicant Contact Sanjay Mehta
Correspondent
Embla Systems
1 Hines Rd.
Suite 202
Kanata,  CA K2K 3C7
Correspondent Contact Sanjay Mehta
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/07/2017
Decision Date 11/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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