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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K213170
Device Name SENSOSEEG Depth Electrodes
Applicant
Sensomedical Labs, Ltd.
Nazareth Industrtial Park
Nazareth,  IL 1612102
Applicant Contact Sama Tarazi
Correspondent
Sensomedical Labs, Ltd.
Nazareth Industrtial Park
Nazareth,  IL 1612102
Correspondent Contact Sama Tarazi
Regulation Number882.1330
Classification Product Code
GZL  
Date Received09/28/2021
Decision Date 04/18/2023
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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