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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 K201678
Device Name iCE-SG Subcutaneous Electrode Arrays
Applicant
iCE Neurosystems, Inc.
1875 Connecticut Ave NW, Suite 12117
Washington,  DC  20009
Applicant Contact Allen Waziri
Correspondent
AcKnowledge Regulatory Strategies, LLC
2251 San Diego Avenue
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison C Komiyama
Regulation Number882.1330
Classification Product Code
GZL  
Date Received06/19/2020
Decision Date 03/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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