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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
510(k) Number K240974
Device Name SPRINT PNS System
Applicant
Spr Therapeutics, Inc.
22901 Millcreek Blvd.
Cleveland,  OH  44122
Applicant Contact Kathryn Stager
Correspondent
Spr Therapeutics, Inc.
22901 Millcreek Blvd.
Cleveland,  OH  44122
Correspondent Contact Kathryn Stager
Regulation Number882.5870
Classification Product Code
SCN  
Date Received04/10/2024
Decision Date 04/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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