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510(k) K251598

Intellidrop by Brainspace, Inc. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2025
Date Received
May 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

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