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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K242113
Device Name Nerve Wrap (07-DW-001-TAB)
Applicant
Biocircuit Technologies, Inc.
1819 Peachtree Rd. NE, Suite 205
Atlanta,  GA  30309
Applicant Contact Jack Griffis
Correspondent
Biocircuit Technologies, Inc.
1819 Peachtree Rd. NE, Suite 205
Atlanta,  GA  30309
Correspondent Contact Jack Griffis
Regulation Number882.5275
Classification Product Code
JXI  
Date Received07/19/2024
Decision Date 04/02/2025
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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