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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, Electrical, Percutaneous (Pens), For Pain Relief
510(k) Number K170902
Device Name Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit
Applicant
SPR Therapeutics, LLC
22901 Millcreek Blvd., Suite 110
Cleveland,  OH  44122
Applicant Contact Kathryn Stager
Correspondent
SPR Therapeutics, LLC
22901 Millcreek Blvd., Suite 110
Cleveland,  OH  44122
Correspondent Contact Kathryn Stager
Regulation Number882.5890
Classification Product Code
NHI  
Date Received03/28/2017
Decision Date 06/26/2017
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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