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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name percutaneous nerve stimulator for opioid withdrawal
510(k) Number K201873
Device Name Sparrow Therapy System
Spark Biomedical, Inc.
18208 Preston Road, Suite D9-531
Dallas,  TX  75252
Applicant Contact Daniel Powell
AcKnowledge Regulatory Strategies, LLC
2251 San Diego Avenue, Suite B-257
San Diego,  CA  92110
Correspondent Contact Michelle Rubin-Onur
Regulation Number882.5896
Classification Product Code
Date Received07/07/2020
Decision Date 01/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04075214
Reviewed by Third Party No
Combination Product No