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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 K250636
Device Name Sophy Mini Monopressure Valve (SM1)
Applicant
Sophysa
5 Rue Guy Moquet
Orsay,  FR 91400
Applicant Contact Lucie Dubois
Correspondent
Sophysa
5 Rue Guy Moquet
Orsay,  FR 91400
Correspondent Contact Lucie Dubois
Regulation Number882.5550
Classification Product Code
JXG  
Date Received03/03/2025
Decision Date 11/28/2025
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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