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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K251598
Device Name Intellidrop
Applicant
Brainspace, Inc.
22121 17th Ave. SE
Suite 112
Bothell,  WA  98021
Applicant Contact Caitlin Morse
Correspondent
Brainspace, Inc.
22121 17th Ave. SE
Suite 112
Bothell,  WA  98021
Correspondent Contact Caitlin Morse
Regulation Number882.5550
Classification Product Code
JXG  
Subsequent Product Code
GWM  
Date Received05/27/2025
Decision Date 12/10/2025
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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