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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 K253970
Device Name Wovyn Depth Electrode
Applicant
Sensomedical Labs, Ltd.
Nazareth Industrial Park, Mount Precipice
Nazareth,  IL 1612102
Applicant Contact Maroun Farah
Correspondent
Sensomedical Labs, Ltd.
Nazareth Industrial Park, Mount Precipice
Nazareth,  IL 1612102
Correspondent Contact Maroun Farah
Regulation Number882.1330
Classification Product Code
GZL  
Date Received12/11/2025
Decision Date 04/17/2026
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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