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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
Applicant
Spark Biomedical, Inc.
18208 Preston Road, Suite D9-531
Dallas,  TX  75252
Applicant Contact Daniel Powell
Correspondent
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
PZR  
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
Predetermined Change
Control Plan Authorized		 No
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