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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K242704
Device Name Synchrony (20-3000)
Applicant
Synapse Biomedical, Inc.
300 Artino St.
Oberline,  OH  44074
Applicant Contact Jason Fiest
Correspondent
Synapse Biomedical, Inc.
300 Artino St.
Oberline,  OH  44074
Correspondent Contact Jason Fiest
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Codes
IPF   KQX  
Date Received09/09/2024
Decision Date 06/05/2025
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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