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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K241917
Device Name EARP Nerve Cuff Electrode
Applicant
Retropsoas Technologies, LLC
34 Countryside Ln.
Frontenac,  MO  63131
Applicant Contact Nicholas Poulos
Correspondent
Watershed Idea Foundry, Inc. (Dba Spitrex 3D)
1815 Aston Ave., Suite 106
Carlsbad,  CA  92008
Correspondent Contact Jeffrey Brittan
Regulation Number874.1820
Classification Product Code
ETN  
Date Received07/01/2024
Decision Date 07/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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