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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 K230796
Device Name Sparrow Ascent
Applicant
Spark Biomedical, Inc.
18208 Preston Rd.
Suite D9-531
Dallas,  TX  75252
Applicant Contact Brent Croft
Correspondent
RQM+
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number882.5896
Classification Product Code
PZR  
Date Received03/22/2023
Decision Date 06/20/2023
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
Recalls CDRH Recalls
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