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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 K260245
Device Name SILKBridge
Applicant
KLISBio S.r.l.
Via Ludovico Ariosto 21
Bresso,  IT 20091
Applicant Contact Gabriele Grecchi
Correspondent
Bruder Consulting and Venture Group
38 True Harbour Way
West Islip,  NY  11795
Correspondent Contact Scott Bruder
Regulation Number882.5275
Classification Product Code
JXI  
Date Received01/27/2026
Decision Date 04/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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