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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 K191739
Device Name Sterile LeadConfirm
Applicant
Alpha Omega Engineering , Ltd.
Nazareth Industrial Park, Mount Precipice, St. 2015
Nazareth,  IL 1612102
Applicant Contact Maysana Mousa
Correspondent
Alpha Omega Engineering , Ltd.
Nazareth Industrial Park, Mount Precipice, St. 2015
Nazareth,  IL 1612102
Correspondent Contact Maysana Mousa
Regulation Number882.1330
Classification Product Code
GZL  
Date Received06/28/2019
Decision Date 01/02/2020
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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