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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 K233166
Device Name NET Recovery Corp/NET Device
Applicant
Net Recovery
155 N Riverview Dr, Suite 114
Anaheim Hills,  CA  92808
Applicant Contact Joe Winston
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number882.5896
Classification Product Code
PZR  
Date Received09/27/2023
Decision Date 05/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04916600
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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